LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No.… recallZ-0131-2023 · Datascope Corporation · initiated Aug 5, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Datascope Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-0131-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 5, 2022
- Posted by the FDA
- Oct 24, 2022
- Recalling firm
- Datascope Corporation
- Quantity
- 4414 OUS
- Product code
- DSQ
- FDA submissions
- K041281
- 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 description
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Code information (models, lots, serial numbers)
UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Linear 7.5Fr. 40cc IAB (with APA) 0684-00-0480-02Datascope Corp. · System, Balloon, Intra-Aortic And Control2 recalls1 death26 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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