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-2432-2023
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 reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
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 reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Critical. Recall number: Z-2432-2023.
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