Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LINEAR 7.5Fr. 40cc IAB with Accessories (APA) Recalled by Datascope Corporation Due to The balloon volume is incorrectly described as 34cc...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datascope Corporation directly.
Affected Products
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Quantity: 4414 OUS
Why Was This 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.
Where Was This Sold?
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.
About Datascope Corporation
Datascope Corporation has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report