The Recall Desk
HighFDA (Devices)·Z-1276-2023·Announced 2023-03-29

Cardiosave Hybrid intra-aortic balloon pump safety disk defect may reduce therapy efficacy

Datascope's Cardiosave Hybrid intra-aortic balloon pump may have a faulty Safety Disk that reduces balloon inflation and cardiac augmentation. No injuries reported.

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 with potential for reduced efficacy in critical cardiac care. No reported illnesses or injuries, but the risk-of-harm in a high-consequence therapeutic setting justifies a rating at the maximum allowable for theoretical hazards without reported injury.

Plain-English summary

Datascope Corp. is recalling 391 Cardiosave Hybrid intra-aortic balloon pumps (IABPs) due to a defect in the Safety Disk that may not meet required performance standards. The affected devices include model numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65.

The Safety Disk defect may impact the intra-aortic balloon catheter's displacement volume, potentially resulting in slightly reduced balloon inflation during therapy or reduced cardiac augmentation to the patient. No illnesses or injuries have been reported. The FDA classified this as a Class II recall.

Patients using these devices and healthcare providers treating them should be aware of this potential issue affecting device performance. The distribution pattern and specific next steps have not yet been publicly released by Datascope Corp.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac / Intra-Aortic Balloon Pump
Hazard
  • device-defect
  • reduced-efficacy

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)

  • Model Number: 0998-00-0800-31
  • UDI-DI: 10607567109053
  • Model Number: 0998-00-0800-32
  • UDI-DI: 10607567111117
  • Model Number: 0998-00-0800-33
  • UDI-DI: 10607567109008
  • Model Number: 0998-00-0800-35
  • UDI-DI: 10607567109107
  • Model Number: 0998-00-0800-45
  • UDI-DI: 10607567108421
  • Model Number: 0998-00-0800-52
  • UDI-DI: 10607567108438
  • Model Number: 0998-00-0800-53
  • UDI-DI: 10607567108391
  • Model Number: 0998-00-0800-55
  • UDI-DI: 10607567108414
  • Model Number: 0998-00-0800-65
  • UDI-DI: 10607567113432
  • Serial Numbers: CB355244F2
  • CB355245F2

Distribution

Distribution scope not specified by the agency.

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