FDA Medical Device Recalls (openFDA)
Datascope Corporation: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
- Recall number
- Z-0131-2023
- Recalling firm
- Datascope Corporation
- Product
- LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
- Status
- Open, Classified
- Initiated
- 2022-08-05
- Posted
- 2022-10-24
- Terminated
- not on file
- 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.
- 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
- 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.
- Lot, serial or model codes
- UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591
- 510(k) numbers
- ["K041281"]
- PMA numbers
- not on file
- Product code
- DSQ
- Firm FEI
- 1000222374
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28