Cardiosave hybrid IABP software defect poses hemodynamic instability and data loss risk
Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of critical cardiac device with software defect. The classification as FDA Class I requires a minimum severity of 4 per regulatory framework. The defect poses risk of hemodynamic instability and data transmission failure, but no injuries or deaths are reported.
Plain-English summary
The FDA is recalling the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) manufactured by Datascope Corp. The device is used to inflate and deflate intra-aortic balloons and has been distributed to more than 50 countries, affecting approximately 5,475 units.
A software defect in the device poses a risk of hemodynamic instability and failure of clinical data transmission. Hemodynamic instability can compromise cardiac function in patients, while data transmission failure may prevent essential clinical information from reaching healthcare providers.
Datascope has developed a software correction (Revision D.00) to mitigate these risks. Affected healthcare facilities should contact Datascope for guidance on implementing this correction.
The recalled product
- Product
- CARDIOSAVE HYBRID 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 (20)
- Product No. 0998-00-0800-31
- 0998-UC-0800-31
- 0998-00-0800-32
- 0998-00-0800-33
- 0998-UC-0800-33
- 0998-00-0800-34
- 0998-00-0800-35
- 0998-00-0800-36
- 0998-00-0800-45
- 0998-00-0800-52
- 0998-UC-0800-52
- 0998-00-0800-53
- 0998-UC-0800-53
- 0998-00-0800-55
- 0998-UC-0800-55
- 0998-00-0800-65
- UDI: 10607567109053
- 10607567111117
- 10607567109008
- 10607567111940
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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