The Recall Desk
CriticalFDA (Devices)·Z-1148-2023·Announced 2023-03-15

Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly

The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA classified this as Class I. Per the rubric, FDA Class I recalls are automatically scored as Critical (5), as unexpected shutdown of this cardiac-support device may interrupt essential therapy and threaten patient hemodynamic stability.

Plain-English summary

Datascope Corp. is recalling Cardiosave Rescue intra-aortic balloon pump (IABP) devices due to the risk of unexpected shutdown. These pumps may stop operating without warning because of a loss of communication between two internal circuit boards: the Executive Processor and the Video Generator.

When an unexpected shutdown occurs, therapy is interrupted, which may threaten the patient's hemodynamic stability—the stability of their blood pressure and circulation. Users may not immediately realize the device has stopped, meaning patients could experience this compromise without awareness.

All serial numbers of the three affected models (0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85) are included in this recall. The devices were distributed worldwide, including throughout the United States and internationally.

The recalled product

Product
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Intra-aortic Balloon Pump
Hazard
  • unexpected-shutdown
  • communication-failure
  • therapy-interruption
  • hemodynamic-instability

Distribution

Distributed nationwide across the United States.

Related recalls

Same category