Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reported: September 6, 2023 Initiated: July 31, 2023 #Z-2438-2023
Product Description
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reason for Recall
Users were identifying autofill failure conditions on the devices causing pump stops.
Details
- Recalling Firm
- Datascope Corp.
- Units Affected
- 9175 units
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85. Recalled by Datascope Corp.. Units affected: 9175 units.
Why was this product recalled? ▼
Users were identifying autofill failure conditions on the devices causing pump stops.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Critical. Recall number: Z-2438-2023.
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