All Recalls

Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.

AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)