The Recall Desk
HighFDA (Devices)·Z-2616-2021·Announced 2021-10-06

Cardiosave Rescue IABP may unexpectedly shut down during operation

Datascope Corp. is recalling the Cardiosave Rescue IABP (models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85) because the device may unexpectedly shut down when run on AC power with a single battery installed and that battery is removed during charging.

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 where the device may unexpectedly shut down under specific battery and power conditions. Although no adverse events have been reported, the device's critical function in cardiac care means an unexpected shutdown presents a risk of harm.

Plain-English summary

Datascope Corp. is recalling the Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. The company distributed 3,969 units in the United States and 3,550 units internationally.

The device may unexpectedly shut down while running on AC power when only one battery is installed in the IABP and the battery is physically removed while being charged. This shutdown occurs only under this specific combination of conditions and does not occur during normal use or with different power or battery configurations.

Healthcare facilities using affected models should review their battery management procedures to ensure they do not inadvertently create the specific conditions that could trigger a shutdown. Consult the user manual or contact Datascope Corp. for additional guidance regarding device operation and battery management.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
Hazard
  • unexpected-shutdown

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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