Recall Z-1148-2023— Datascope Corp.

Name: FDA recall Z-1148-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-07

Class I · Ongoing

Class I FDA medical device recall by Datascope Corp., initiated 2023-02-07. It names one FDA 510(k) clearance: K181122. Product: Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85. Reason: An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP..

Recalling firm: Datascope Corp.
Classification: Class I
Status: Ongoing
Initiated: 2023-02-07
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 Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Reason for recall

An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.

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