The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2486-2023·Announced 2023-09-06

Cardiosave Hybrid Intra-Aortic Balloon Pump Fiber Optic Sensor Failure

Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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: FDA Class II medical device recall involving a documented sensor failure on critical cardiac support equipment. No illnesses or injuries have been reported, but the potential for device malfunction on life-sustaining cardiac support equipment poses significant risk to vulnerable patients.

Plain-English summary

Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) manufactured under multiple part numbers. The intra-aortic balloon pump is a critical medical device used in hospitals to support patients with severe heart conditions.

The recall addresses a failure in the Fiber Optic Sensor input on affected pumps. Users have reported that this sensor fails when inserting the Intra-Aortic Balloon Fiber Optic connector during device setup. A sensor failure could prevent the pump from operating correctly.

The affected units were distributed nationwide in the United States as well as globally. All lot numbers of the affected models are included in this recall. Healthcare providers using these devices should immediately contact Datascope Corp. for instructions on device replacement or repair. Patients currently using affected equipment should discuss the recall with their healthcare provider.

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…
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
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 (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
  • 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
  • UDI:10607567108391

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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