Recall Z-0986-2019— Maquet Cardiovascular Us Sales, Llc

Name: FDA recall Z-0986-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-08

Class I · Terminated

Class I FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2019-02-08, terminated 2020-05-14. It names one FDA 510(k) clearance: K102726. Product: Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.. Reason: Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive..

Recalling firm: Maquet Cardiovascular Us Sales, Llc
Classification: Class I
Status: Terminated
Initiated: 2019-02-08
Terminated: 2020-05-14
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102726 — CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG·cleared 2011-04-04

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

Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.

Reason for recall

Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.

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