|
 
Today, the U.S. Food and Drug Administration (FDA) is providing an update for Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA is issuing this letter to help ensure health care providers are aware of the latest recalls and recommendations to users.
Since June 2023, Getinge/Maquet/Datascope initiated additional voluntary recalls related to the potential for device failure with Cardiosave IABP devices and provided mitigation strategies. Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops). The FDA continues to closely monitor issues with Cardiosave IABP devices.
The FDA has identified six of these latest recalls as Class I recalls, the most serious type of recall. Please be aware, these recalls are voluntary corrections, not product removals.
The Letter to Health Care Providers includes important information about this issue, including:
- Recommendations for health care providers,
- Actions the FDA is taking to address the issue,
- How to report any issues with IABPs to the FDA.
Questions?
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
|
|
|
|
