The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0337-2022·Announced 2021-12-22

FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress

Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system 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 classification requires a minimum severity of 4 per the rubric. The hazard involves potential electronic failure in a critical cardiac-support device used for hemodynamic stabilization. While no reported illnesses or deaths are mentioned in the source, the serious nature of potential system failure in life-support equipment justifies the Severe rating.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Rescue Intra-Aortic Balloon Pump, affecting multiple model numbers (0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85) with all serial numbers.

The firm initiated this recall due to the possibility of fluid ingress into the device. Fluid entering the device may short various electronic components, leading to system shutdown. This could result in unsafe hemodynamic instability.

The affected devices have been distributed worldwide, including nationwide in the United States (44 units in the US, 5 units outside the US).

The recalled product

Product
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
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)

  • UDI-DI: 0998-00-0800-75
  • 10607567112312
  • 0998-UC-0800-75
  • 0998-00-0800-83
  • 10607567108407
  • 0998-UC-0800-83
  • 0998-00-0800-85
  • 10607567113449
  • 0998-UC-0800-85
  • 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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