medical MODERATE Updated 2025-12-17

Datascope Corp. recalls Cardiosave Rescue. Intra-Aortic Balloon Pump system.

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Recalled Product

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

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Hazard / Issue

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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