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Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to alert facilities and providers about a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts. The FDA is working with Getinge to identify potential strategies to help support availability of these critical devices.
The Letter to Health Care Providers includes important information about this supply shortage, including:
- Recommendations for health care facilities and providers
- Instructions for reporting problems and supply chain issues to the FDA
In addition, the FDA has added IABP devices (product code DSP) to the medical device shortage list.
If you have questions about this letter to healthcare providers, contact the Division of Industry and Consumer Education.
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