Class I Recall of Batteries for Cardiosave Hybrid/Rescue IABPs: FDA

Certain battery packs for the Cardiosave Hybrid and Rescue intra-aortic balloon pumps (IABPs) are being recalled by their manufacturer, the US Food and Drug Administration announced today.

This follows several other recalls related to Cardiosave IABPs, including a 2019 Class I recall of batteries for all lots and manufacturing and distribution dates for a range of IABP models.

The agency has also categorized the latest alert as Class I, its most serious type, because use of affected products could result in serious injury or death. Thus far, Datascope/Getinge/Maquet have received six complaints related to the substandard batteries but no reports of injury or death.

A total of 137 battery packs distributed from September 23, 2017, to August 17, 2021, are affected in the current recall.

Datascope/Getinge/Maquet sent a “Urgent Medical Device Removal" letter on September 21, 2021, alerting customers to the risk that the two products’ batteries may fail or have a shortened run time.

This “may cause the device to stop working when operated by battery only,” the FDA says, adding, “Both Cardiosave Hybrid and Rescue IABP monitors display battery life to the user, prompting intervention with low battery alarms when alternative power sources are indicated.”

Healthcare providers should determine if their Cardiosave Hybrid or Rescue IABPs contain a Li-Ion battery pack with Part Number/REF Number 0146-00-0097, and if so, check for recalled serial numbers here. Any affected batteries should be replaced by an unaffected battery. Users of recalled products can obtain a free replacement battery from Datascope/Getinge/Maquet.