FDA designates recall of two intra-aortic balloon pumps as class I
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Key takeaways:
- Datascope/Maquet/Getinge intra-aortic balloon pumps recalled due to risk for unexpected shutdown.
- The FDA has identified this recall as class I, the most serious type.
The FDA announces a recall of intra-aortic balloon pumps manufactured by Datascope/Maquet/Getinge due to risk for unexpected shutdown due to electrical failure in the power management or solenoid boards.
The FDA has identified this recall as class I, the most serious type, as use of these intra-aortic balloon pumps (IABPs; Cardiosave Hybrid and Rescue) may cause serious adverse events, including unstable BP, injury and death.
The recalled IABPs are indicated for ACS, cardiac and noncardiac surgery or complications due to HF in adults, according to an FDA press release.
The recall includes 4,586 devices distributed between March 6, 2012, and May 19, 2023.
The company reported 26 complaints and no injuries or deaths related to the issue.
On Aug. 31, 2023, the FDA provided an letter to health care providers on the companies’ recall of their IABP overviewing six points of unexpected shutdown or interrupted therapy:
- Electrical failure in the power source path.
- Printed circuit board assembly failure in the charging path.
- The device not being seated into the cart, rendering the device unable to charge the batteries.
- The device is unable to refill helium, which halts therapy.
- Sensitive high priority Gas Gain or Gas Loss alarms, which will halt therapy.
- Internal device temperature exceeds 80° C (176° F), which halts therapy.
The FDA also issued recommendations to users of these devices, including having additional charged IABP devices available in the event of device failure and to review the recent urgent medical device correction notices issues by the companies.
Please see the FDA’s letter to health care providers for full details on the latest recalls and FDA recommendations.
Editor’s Note: This article was updated on Aug. 31, 2023 to add information about the FDA’s new communication.
Reference:
- UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers. https://www.fda.gov/medical-devices/letters-health-care-providers/update-risk-device-failures-getinges-maquetdatascope-cardiosave-intra-aortic-balloon-pump-iabp. Published Aug. 31, 2023. Accessed Aug. 31, 2023.
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