Medical equipment, implants, and diagnostic devices
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
Ethicon Endo-Surgery
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Problem with packaging sealing process which affects sterility.
Valeritas, Incorporated
There is a potential for "No Needle Demo Units" to contain a needle.
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
Alto Development
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
Ethicon Endo-Surgery
The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
There is an electronics control issue that causes the unit to not power on with battery power only.
GE Healthcare
Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.
Valeritas, Incorporated
There is a potential for "No Needle Demo Units" to contain a needle.
Alto Development
Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning, rendering the tensioner inoperable.
Synthes (USA) Products
The subject product measures 4.0mm in diameter instead of 3.5mm.
Thoratec Switzerland GMBH
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Centurion Medical Products
Supplier initiated recall of the GRIPPER Needles
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
TIDI PRODUCTS
Not meeting design specifications.