Cardiac Support Device Software Defect Risks Hemodynamic Instability
Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue…"
Plain-English summary
The CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP), manufactured by Datascope Corp., is an electromechanical cardiac support device used to inflate and deflate intra-aortic balloons. A software defect poses a risk of hemodynamic instability and failure of transmission of clinical data.
Approximately 5,475 units have been distributed internationally to 49 countries and territories including the United Arab Emirates, Argentina, Australia, Brazil, Canada, China, Germany, France, India, Japan, South Korea, Mexico, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and the United Kingdom. All lots of the affected product numbers are included in this recall.
Datascope Corp. has developed a software correction (Revision D.01) for affected devices outside the United States. Healthcare facilities and clinicians should implement this update to mitigate the risks of hemodynamic instability and clinical data transmission failure.
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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