Recall Z-2487-2023— Datascope Corp.
Class II · Ongoing
Class II FDA medical device recall by Datascope Corp., initiated 2023-07-31. It names one FDA 510(k) clearance: K181122. Product: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85. Reason: Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector..
- Recalling firm
- Datascope Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-31
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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 experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.