FDA designates intra-aortic balloon pump recall as class I
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The FDA announced it has designated a recall of intra-aortic balloon pumps by Datascope/Getinge as class I, the most serious kind.
The recall occurred because the coiled cable connecting the display and the base might fail in some units of the intra-aortic balloon pumps (IABPs; Cardiosave Hybrid and Cardiosave Rescue), causing the unit to shut down without warning, according to an alert issued by the agency.
The affected units were distributed before July 24, 2017, and/or had coiled cord part number 0012-00-1801, according to the alert.
The company reported 44 complaints related to the issue between June 2019 and August 2022, but there have been no reports of injuries or deaths from it, according to the alert.
If a shutdown occurs, the unit will not work again unless the cable is replaced, according to the alert.
On March 31, the recall was expanded to all devices distributed between March 6, 2012, and Jan. 13, 2023, due to unexpected shutdowns caused by communication loss between the executive processor printed circuit board assembly and the video generator printed circuit board assembly.
This shutdown will occur without warning and one or both of the printed circuit board assemblies must be replaced for the device to work again, according to an FDA alert.
The company reported 42 complaints about unexpected shutdowns due to printed circuit board assembly communication failure, but there have been no reports of injuries or deaths from it, according to the alert.
If a shutdown occurs, the unit will not work again unless the cable is replaced, according to the alert.
The IABPs are indicated for ACS, cardiac and noncardiac surgery and complications of HF in adult patients.
Unexpected shutdowns leading to interruption of therapy can cause hemodynamic instability, organ damage and/or death, especially in critically ill patients, the FDA stated in the alert.
Reference:
- Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss. https://www.fda.gov/medical-devices/medical-device-recalls/recall-datascopegetinge-certain-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-risk. Published March 31, 2023. Accessed March 31, 2023.
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