Infusion Pumps

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

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There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.