Recall Z-2486-2023— Datascope Corp.

Name: FDA recall Z-2486-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-31

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 Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65. 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 record

K181122 — CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.·cleared 2018-05-31

K-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 Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

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.