The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2434-2023·Announced 2023-09-06

Cardiosave Rescue IABP Pumps Recalled for System Overheating and Pump Failure

Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.

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: FDA Class I recall requires a minimum severity score of 4. The source describes functional failures of a critical cardiac support device but does not report actual deaths or injuries, which would elevate this to Critical.

Plain-English summary

Datascope Corp. has issued a Class I recall of Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), affecting 47 units globally (42 in the US, 5 distributed internationally). All lot numbers are affected for the six part numbers listed in the recall.

Users have reported "System Over Temperature" alarms associated with loss of pumping function and/or the device entering Standby mode. These malfunctions represent a functional failure of this critical cardiac support device.

Healthcare facilities using these devices should immediately cease use of the recalled units and contact Datascope Corp. for guidance on replacement or remediation options.

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, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
Hazard

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 (10)

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

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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