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Getinge’s Maquet/Datascope IABP Devices: Update on Device Failure - Letter to Health Care Providers
Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to provide updated information about device failures, such as unexpected shutdowns while on AC/wall power, associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices, which include the Cardiosave (Hybrid and Rescue), CS300, and CS100/CS100i.
The manufacturer recently announced three voluntary recalls for Cardiosave Hybrid and Rescue IABP devices related to the potential for device failure.
The Letter to Health Care Providers includes important information about the ongoing evaluation of device failures associated with Getinge’s Maquet/Datascope IABP devices, including:
- Details on the manufacturer’s most recent voluntary recalls for Cardiosave IABP devices.
- Recommendations for Cardiosave IABP device users and servicers.
- Actions the FDA continues to take to understand and address the potential for Maquet/Datascope IABP device failure while running on battery or AC/wall power.
- Instructions for reporting problems with a device.
The FDA is encouraging health care providers who treat patients with any Maquet/Datascope IABP to promptly report device failures to the FDA.
Questions?
If you have questions about this device, contact the Division of Industry and Consumer Education (DICE).
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