FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.
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 classification requires a minimum severity of 4 per the rubric. The hazard involves potential electronic failure in a critical cardiac-support device used for hemodynamic stabilization. While no reported illnesses or deaths are mentioned in the source, the serious nature of potential system failure in life-support equipment justifies the Severe rating.
Plain-English summary
Datascope Corp. is recalling the Cardiosave Rescue Intra-Aortic Balloon Pump, affecting multiple model numbers (0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85) with all serial numbers.
The firm initiated this recall due to the possibility of fluid ingress into the device. Fluid entering the device may short various electronic components, leading to system shutdown. This could result in unsafe hemodynamic instability.
The affected devices have been distributed worldwide, including nationwide in the United States (44 units in the US, 5 units outside the US).
The recalled product
- Product
- Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiac Support
- Hazard
- fluid-ingress
- electrical-short
- system-shutdown
- hemodynamic-instability
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 (10)
- UDI-DI: 0998-00-0800-75
- 10607567112312
- 0998-UC-0800-75
- 0998-00-0800-83
- 10607567108407
- 0998-UC-0800-83
- 0998-00-0800-85
- 10607567113449
- 0998-UC-0800-85
- 10607567113449.
Distribution
Distributed nationwide across the United States.
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