Recall Z-1462-2023— Datascope Corp.

Name: FDA recall Z-1462-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-04

Class II · Ongoing

Class II FDA medical device recall by Datascope Corp., initiated 2023-04-04. It names one FDA 510(k) clearance: K112372. Product: MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32. Reason: The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle..

Recalling firm: Datascope Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-04
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, Model Number 0998-XX-0800-32

Reason for recall

The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.

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