Z-0131-2023Class II

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

Name: Z-0131-2023 LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter
Creator: Datascope Corporation
Published: 2022-08-05
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2022-08-05 / Open, Classified / root cause: labeling and UDI

FDA source

Datascope Corporation began a recall of LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter on 2022-08-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0131-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-05
Posted: 2022-10-24
Recalling firm: Datascope Corp.
Product: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On August 5, 2022, the firm notified affected customers via Urgent Field Safety Notice Medical Device Removal letters. Customers were instructed to examine their inventory for the affected product. Customers may return the product for full credit. The firm also informed customers that given current supply chain shortages that they are unable to commit to a timely replacement of affected catheters.
Quantity in commerce: 4414 OUS
Distribution: No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay.
Product codes and lots: UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0131-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0131-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-24

Product code DSQ

K041281Class IIDatascope 7.5Fr. Iab Catheter and AccessoriesDatascope Corp. / cleared 2004-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)