Cardiosave Rescue IABP Recalled Due to Unexpected Shutdown Risk
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to capacitor failures that may cause unexpected device shutdown. The devices may stop delivering therapy without warning.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification requires a severity score of at least 4 per the rubric. While no injuries or deaths have been reported in the source, the potential for unexpected shutdown of a life-support device presents serious harm risk.
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. A total of 9,174 units were distributed worldwide, including 4,586 in the United States.
The IABP may unexpectedly shut down due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This unexpected shutdown can interrupt therapy delivery to the patient.
Healthcare facilities and clinicians using these devices are affected by this recall. Owners of recalled devices should contact Datascope Corp. for instructions on replacement or repair.
The recalled product
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
- Manufacturer
- Datascope Corp.
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.
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