Cardiosave IABP may shut down unexpectedly due to blood contamination
The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.
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: This is an FDA Class I recall, the highest regulatory classification for medical devices. FDA Class I designates devices with a reasonable probability of causing serious adverse health consequences or death.
Plain-English summary
The Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), manufactured by Datascope Corp., including Models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, and 0998-UC-0800-85, is the subject of this FDA Class I recall.
The device may shut down unexpectedly when therapy is provided with a compromised intra-aortic balloon catheter, as blood may enter the pump during operation.
Approximately 46 units have been distributed worldwide, including throughout the United States and internationally to numerous countries.
Healthcare facilities currently using or possessing this device should contact Datascope Corp. immediately for guidance on appropriate next steps and device management.
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, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
- Manufacturer
- Datascope Corp.
- Affected units
- 46
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)
- UDI-DI: 0998-00-0800-75
- 10607567112312
- 0998-00-0800-83
- 10607567108407
- 0998-00-0800-85
- 10607567113449
- 0998-UC-0800-75
- 0998-UC-0800-83
- 0998-UC-0800-85
- 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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