Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to misbranded products shipped to customers.
Due to misbranded products shipped to customers.
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
Incorrect Peel-Apart Introducer Sheath in Kit.
Incorrect Peel-Apart Introducer Sheath in Kit.
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Sterility compromised due to packaging pouches that may not be sealed properly
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention.
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F introducer sheath could result in difficulty or the inability to insert or advance the catheter through the introducer sheath. This could potentially lead to a slight prolongation of the procedure.
Complaints received that products packaged with the incorrect introducer sheath size.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.