Recall Z-0131-2023— Datascope Corporation

Name: FDA recall Z-0131-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-05

Class II · Ongoing

Class II FDA medical device recall by Datascope Corporation, initiated 2022-08-05. It names one FDA 510(k) clearance: K041281. Product: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.. Reason: The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable..

Recalling firm: Datascope Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-08-05
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K041281 — DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIESDatascope Corp.·cleared 2004-06-07

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

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Reason for recall

The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

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