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.
Reported: December 22, 2021 Initiated: November 15, 2021 #Z-0337-2022
Product Description
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.
Reason for Recall
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Details
- Recalling Firm
- Datascope Corp.
- Units Affected
- 44 (US); 5 (OUS)
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Datascope Corp.. Units affected: 44 (US); 5 (OUS).
Why was this product recalled? ▼
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 22, 2021. Severity: Critical. Recall number: Z-0337-2022.
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