Recall Z-0099-2019— Maquet Datascope Corp - Cardiac Assist Division

Name: FDA recall Z-0099-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-20

Class I · Ongoing

Class I FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2018-09-20. It names one FDA 510(k) clearance: K181122. Product: Cardiosave Hybrid IABP, Part Number 0998-00-0800-53. Reason: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft..

Recalling firm: Maquet Datascope Corp - Cardiac Assist Division
Classification: Class I
Status: Ongoing
Initiated: 2018-09-20
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 IABP, Part Number 0998-00-0800-53

Reason for recall

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

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