Recall Z-1907-2023— Datascope Corp.

Name: FDA recall Z-1907-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Class III · Ongoing

Class III FDA medical device recall by Datascope Corp., initiated 2023-05-04. It names one FDA 510(k) clearance: K112372. Product: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX. Reason: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU..

Recalling firm: Datascope Corp.
Classification: Class III
Status: Ongoing
Initiated: 2023-05-04
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

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Reason for recall

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

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