CARDIOSAVE Rescue IABP software defect poses hemodynamic instability risk
Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.
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—the agency's highest medical device classification. The software defect poses a risk of hemodynamic instability in a cardiac support device used in critical care, which could result in serious patient harm.
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 to support heart function. The recall affects 5,475 units distributed internationally to more than 50 countries.
The devices contain a software defect that poses a risk of hemodynamic instability—a dangerous change in blood pressure and circulation—and may prevent the transmission of clinical data to clinicians. Datascope has developed a software correction (Revision D.00) to mitigate these risks.
The IABP is used in critical care and cardiothoracic surgery settings to support patients with seriously compromised heart function. Healthcare facilities using these devices should implement the software correction. Patients should consult their healthcare provider if they have concerns about the safety of devices currently in use.
The recalled product
- Product
- CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiac Support
- 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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