Cardiosave Rescue Intra-Aortic Balloon Pumps Recalled Due to Autofill Failure
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failures that can cause the pump to stop.
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: This is an FDA Class I recall of a critical cardiac support device. The autofill failure can cause pump stops, preventing the device from functioning as intended in life-critical applications.
Plain-English summary
Datascope Corp. is recalling 9,175 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) worldwide. The recalled devices include Part Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85, affecting all lot numbers.
The devices have been identified as having autofill failure conditions that can cause the pump to stop during operation. This malfunction prevents the devices from performing their intended critical cardiac support function.
These pumps are used in hospitals and critical care settings. Healthcare providers who use these devices should contact Datascope Corp. for information about the recall and next steps.
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
- Manufacturer
- Datascope Corp.
- Affected units
- 9,175
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 (6)
- All Lot Numbers. Model: 0998-00-0800-75
- UDI: 10607567112312
- Model: 0998-00-0800-83
- UDI: 10607567108407
- Model: 0998-00-0800-85
- UDI: 10607567113449
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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