The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1231-2023·Announced 2023-03-15

Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy

Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.

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: This is a risk-of-harm product (intra-aortic balloon pump with reported O-ring defects causing therapy interruption potential) where injury has not yet been reported, meeting the criteria for Score 3 per the severity rubric.

Plain-English summary

The Cardiosave Hybrid Intra-Aortic Balloon Pump, manufactured by Datascope Corp., has been recalled. Approximately 11,792 units have been distributed nationwide in the United States and internationally across multiple model numbers.

Reports indicate that O-rings on the pump console quick disconnect fitting may be damaged, worn, or torn. These defective O-rings result in helium tank leaks. If the helium supply is depleted, the pump's cardiac support therapy will be interrupted.

Affected model numbers include D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, and D998-UC-0800-55.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31…
Manufacturer
Datascope Corp.
Category
Medical Device — Intra-aortic Balloon Pump
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 (16)

  • Model Number (UDI-DI): D998-00-0800-31 (10607567109053¿)
  • D998-00-0800-32 (10607567111117)
  • D998-00-0800-33 (10607567109008)
  • D998-00-0800-35 (10607567109107)
  • D998-00-0800-36 (10607567114187)
  • D998-00-0800-45 (10607567108421)
  • D998-00-0800-52 (10607567108438)
  • D998-00-0800-53 (10607567108391)
  • D998-00-0800-55 (10607567108414)
  • D998-00-0800-65 (10607567113432)
  • D998-00-0800-83 (10607567108407)
  • D998-UC-0800-31 (10607567109053)
  • D998-UC-0800-33 (10607567109008)
  • D998-UC-0800-52 (10607567108438)
  • D998-UC-0800-53 (10607567108391)
  • D998-UC-0800-55 (10607567108414). All serial numbers

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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