The Recall Desk
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.

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: 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, 0998-00-08
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
Hazard
  • fiber-optic-sensor-failure

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.

Related recalls

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