Recall Z-1587-2026— Datascope Corp.

Name: FDA recall Z-1587-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-06

Class III · Ongoing

Class III FDA medical device recall by Datascope Corp., initiated 2026-02-06. It names one FDA 510(k) clearance: K112372. Product: Battery Charging Station; Model: 0998-00-0802;. Reason: The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue..

Recalling firm: Datascope Corp.
Classification: Class III
Status: Ongoing
Initiated: 2026-02-06
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

Battery Charging Station; Model: 0998-00-0802;

Reason for recall

The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

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