The Recall Desk
SevereFDA (Devices)·Z-2152-2023·Announced 2023-07-26

Cardiosave Rescue IABP Recalled Due to Unexpected Shutdown Risk

Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to capacitor failures that may cause unexpected device shutdown. The devices may stop delivering therapy without warning.

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 recall classification requires a severity score of at least 4 per the rubric. While no injuries or deaths have been reported in the source, the potential for unexpected shutdown of a life-support device presents serious harm risk.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. A total of 9,174 units were distributed worldwide, including 4,586 in the United States.

The IABP may unexpectedly shut down due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This unexpected shutdown can interrupt therapy delivery to the patient.

Healthcare facilities and clinicians using these devices are affected by this recall. Owners of recalled devices should contact Datascope Corp. for instructions on replacement or repair.

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 Device
Hazard
  • device-shutdown
  • component-failure
  • therapy-interruption

Distribution

Distributed nationwide across the United States.

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