The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1230-2023·Announced 2023-03-15

Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

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 an FDA Class II medical device recall affecting a critical care pump. Although no illnesses or injuries have been reported, the helium regulator failure directly impairs device functionality and poses risk to patients requiring cardiac support.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) in three model numbers: 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. All serial numbers of these models are affected.

When the high-pressure helium regulator fails, the Pump Console's internal helium reservoir is not replenished when docked into an affected Hospital Cart. This can result in an insufficient amount of helium within the internal reservoir, potentially affecting the device's operation.

The recall involves 8,909 units distributed nationwide in the United States and globally.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Critical Care / Cardiac Support
Hazard
Affected units
8,909

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 Serial Numbers. Model Number: 0998-00-0800-75
  • UDI-DI: 10607567112312
  • Model Number: 0998-00-0800-83
  • UDI-DI: 10607567108407
  • Model Number: 0998-00-0800-85
  • UDI-DI: 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 →

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