Recall Z-1140-2015— Maquet Datascope Corp - Cardiac Assist Division

Name: FDA recall Z-1140-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-30

Class II · Terminated

Class II FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2015-01-30, terminated 2017-09-29. It names one FDA 510(k) clearance: K112372. Product: Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP). Reason: Power supply malfunction complaints related to suboptimal thermal management..

Recalling firm: Maquet Datascope Corp - Cardiac Assist Division
Classification: Class II
Status: Terminated
Initiated: 2015-01-30
Terminated: 2017-09-29
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC·cleared 2011-09-15

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

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Reason for recall

Power supply malfunction complaints related to suboptimal thermal management.

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