Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Siemens Medical Solutions USA
Class I - Dangerous
Software update
Hitachi Oasis MRI System
Hitachi Medical Systems America
Class I - Dangerous
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Haag-Streit USA
Class I - Dangerous
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare
Class I - Dangerous
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Class I - Dangerous
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Merge Healthcare
Class I - Dangerous
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
ARTIS Q, Interventional Fluroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
Software updates
The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
Class I - Dangerous
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Crossroads Extremity Systems
Class I - Dangerous
Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Devicor Medical Products
Class I - Dangerous
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Vygon MFG, Inc., dba/ Churchill Medical Systems
Class I - Dangerous
Incorrect priming volume printed on the device package.