Cardiosave Rescue IABP Pumps Recalled for System Overheating and Pump Failure
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to system overheating alarms that can cause loss of pumping function and device shutdown.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall requires a minimum severity score of 4. The source describes functional failures of a critical cardiac support device but does not report actual deaths or injuries, which would elevate this to Critical.
Plain-English summary
Datascope Corp. has issued a Class I recall of Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), affecting 47 units globally (42 in the US, 5 distributed internationally). All lot numbers are affected for the six part numbers listed in the recall.
Users have reported "System Over Temperature" alarms associated with loss of pumping function and/or the device entering Standby mode. These malfunctions represent a functional failure of this critical cardiac support device.
Healthcare facilities using these devices should immediately cease use of the recalled units and contact Datascope Corp. for guidance on replacement or remediation options.
The recalled product
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
- Manufacturer
- Datascope Corp.
- Hazard
- thermal-malfunction
- pump-failure
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 (10)
- All Lot Numbers. Model: 0998-00-0800-75
- UDI: 10607567112312
- Model: 0998-00-0800-83
- UDI: 10607567108407
- Model: 0998-00-0800-85
- UDI: 10607567113449
- Model: 0998-UC-0800-75
- UDI: N/A
- Model: 0998-UC-0800-83
- Model: 0998-UC-0800-85
Distribution
Distributed nationwide across the United States.
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