The Recall Desk
HighFDA (Devices)·Z-2487-2023·Announced 2023-09-06

Intra-Aortic Balloon Pumps Fiber Optic Sensor Input Failure Recalled

Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries, illnesses, or deaths. Because no harm has been reported despite the identified sensor failure risk, this meets the 'High' severity criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. Approximately 9,379 units are affected across all lot numbers.

The recalled devices experience a failure in the intra-aortic balloon fiber optic sensor input when inserting the fiber optic connector. Users have reported this failure during connector insertion, which could impact proper device operation.

These devices are distributed nationwide in the United States and globally for use as cardiac support equipment in clinical settings.

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
9,379

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 →

Related recalls

Same manufacturer · Datascope Corp.

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Same hazard · sensor failure

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