The Recall Desk
SevereFDA (Devices)·Z-2150-2023·Announced 2023-07-26

Intra-Aortic Balloon Pump may fail to charge batteries, interrupting therapy

The Cardiosave Rescue Intra-Aortic Balloon Pump may lose battery charging ability in one or both bays, potentially interrupting therapy if disconnected from power. Low battery alarms may alert users before therapy stops.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification by the agency reflects serious potential for patient harm. Although no illnesses or injuries have been reported, the possibility of therapy interruption in a device providing critical cardiac support warrants this severity level.

Plain-English summary

The FDA has recalled the Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Models 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85, manufactured by Datascope Corp. The devices may lose the ability to charge batteries in one or both battery bay slots. If batteries fail to charge and the device is disconnected from AC power, cardiac support therapy may be interrupted.

Approximately 9,174 units have been distributed worldwide, including 4,586 in the United States. Low battery alarms may alert users to this issue before therapy interruption occurs.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
Hazard
  • battery-charge-failure
  • therapy-interruption

Distribution

Distributed nationwide across the United States.

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