Recall Z-1248-2016— Maquet Datascope Corp - Cardiac Assist Division

Name: FDA recall Z-1248-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-16

Class II · Terminated

Class II FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2015-12-16, terminated 2018-06-01. It names one FDA 510(k) clearance: K112372. Product: Cardiosave Hybrid and rescue IABP. Reason: Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates..

Recalling firm: Maquet Datascope Corp - Cardiac Assist Division
Classification: Class II
Status: Terminated
Initiated: 2015-12-16
Terminated: 2018-06-01
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

Cardiosave Hybrid and rescue IABP

Reason for recall

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

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