The Recall Desk
SevereFDA (Devices)·Z-2437-2023·Announced 2023-09-06

Cardiosave Hybrid Intra-Aortic Balloon Pumps recalled for autofill failure

Datascope Corp. is recalling Cardiosave Hybrid intra-aortic balloon pumps due to autofill failure causing pump stops. The FDA Class I recall affects approximately 9,175 units distributed nationwide.

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: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. No deaths or serious injuries are reported in the source text, preventing a score of 5. The critical nature of the medical device and its failure mode justify a Severe rating.

Plain-English summary

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), manufactured by Datascope Corp., are subject to a Class I recall issued by the FDA. Approximately 9,175 units across multiple model numbers and all lot numbers have been affected.

Users identified autofill failure conditions on these devices that cause pump stops. The FDA has classified the malfunction as a Class I recall due to the serious nature of the failure mode.

The affected devices have been distributed nationwide. The recall applies to all lot numbers of the involved product models.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support / Intra-Aortic Balloon Pump
Hazard
  • autofill-failure
  • pump-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All Lot Numbers. Model: 0998-00-0800-31
  • UDI: 10607567109053
  • Model: 0998-UC-0800-31
  • UDI: N/A
  • Model: 0998-00-0800-32
  • UDI: 10607567111117
  • Model: 0998-00-0800-33
  • UDI: 10607567109008
  • Model: 0998-UC-0800-33
  • UDI: N/A
  • Model: 0998-00-0800-34
  • UDI: 10607567111940
  • Model: 0998-00-0800-35
  • UDI: 10607567109107
  • Model: 0998-00-0800-45
  • UDI: 10607567108421
  • Model: 0998-00-0800-52
  • UDI: 10607567108438
  • Model: 0998-UC-0800-52
  • Model: 0998-00-0800-53

Distribution

Distributed nationwide across the United States.

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