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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Although this is an FDA Class I recall, no illnesses, injuries, or deaths have been reported. The hazard is described as a theoretical risk of hemodynamic instability and data transmission failure, fitting the FDA rubric category of risk-of-harm products without reported injury, which defines the High category.
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.
- Hazard
- hemodynamic-instability
- data-transmission-failure
- software-defect
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.
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