The Recall Desk
HighFDA (Devices)·Z-2615-2021·Announced 2021-10-06

Cardiosave Hybrid IABP may unexpectedly shut down on AC power

The Cardiosave Hybrid Intra-Aortic Balloon Pump may unexpectedly shut down when running on AC power with one battery installed and the battery removed during charging. No injuries have been 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 recall with no reported illnesses or injuries. The hazard is functional—device malfunction under specific conditions. Per rubric criteria for risk-of-harm products without documented harm, severity is High.

Plain-English summary

The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), manufactured by Datascope Corp., may unexpectedly shut down when operating under a specific combination of conditions: running on AC power with only one battery installed, and the battery being physically removed while charging.

This recall affects all lots of 10 model numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 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. A total of 3,969 units were distributed in the United States and 3,550 units were distributed internationally.

No injuries or deaths have been reported related to this issue. Healthcare facilities using affected units should contact Datascope Corp. for further information and guidance.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
Hazard
  • unexpected-shutdown
  • device-malfunction

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

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