Recall Z-1232-2023— Datascope Corp.

Name: FDA recall Z-1232-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-07

Class II · Ongoing

Class II FDA medical device recall by Datascope Corp., initiated 2023-02-07. It names one FDA 510(k) clearance: K181122. Product: Cardiosave Rescue. Model Number: 0998-00-0800-83.. Reason: Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted..

Recalling firm: Datascope Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-07
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 Rescue. Model Number: 0998-00-0800-83.

Reason for recall

Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

Data sourced from openFDA. This site is unofficial and independent of the FDA.