medical Class I Updated 2023-07-26

Datascope Corp. recalls Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model nu

Recalled Product

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85


Hazard / Issue

An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Unit Serial Numbers Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449
View official government recall

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