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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
Distribution
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.
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