The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2438-2023·Announced 2023-09-06

Cardiosave Rescue Intra-Aortic Balloon Pumps Recalled Due to Autofill Failure

Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of a critical cardiac support device. The autofill failure can cause pump stops, preventing the device from functioning as intended in life-critical applications.

Plain-English summary

Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) worldwide. The recalled devices include Part Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85, affecting all lot numbers.

The devices have been identified as having autofill failure conditions that can cause the pump to stop during operation. This malfunction prevents the devices from performing their intended critical cardiac support function.

These pumps are used in hospitals and critical care settings. Healthcare providers who use these devices should contact Datascope Corp. for information about the recall and next steps.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
Hazard
Affected units
9,175

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 (6)

  • All Lot Numbers. Model: 0998-00-0800-75
  • UDI: 10607567112312
  • Model: 0998-00-0800-83
  • UDI: 10607567108407
  • Model: 0998-00-0800-85
  • UDI: 10607567113449

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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