CARDIOSAVE RESCUE intra-aortic balloon pump software correction for hemodynamic instability
Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.
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 medical device classification requires a minimum severity score of Severe (4) per the recall rubric. No illnesses or injuries are reported in the source text, so the score does not elevate to Critical (5).
Plain-English summary
Datascope Corp. is recalling the CARDIOSAVE RESCUE Intra-Aortic Balloon Pump (IABP), an electromechanical system used to inflate and deflate intra-aortic balloons. Approximately 5,475 units have been distributed internationally.
The devices carry a risk of hemodynamic instability and failure to transmit clinical data. Datascope Corp. has developed a software correction (Revision D.01) to mitigate these risks.
Healthcare facilities and clinicians using affected devices may contact Datascope Corp. to obtain the software correction. The FDA classified this as a Class I recall.
The recalled product
- Product
- CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
- Manufacturer
- Datascope Corp.
- Affected units
- 5,475
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 (7)
- Product No. 0998-00-0800-75
- 0998-00-0800-83
- 0998-00-0800-85
- UDI: 10607567112312
- 10607567108407
- 10607567113449
- Lot No. ALL LOTS.
Distribution
Distribution scope not specified by the agency.
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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