Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter Recalled by AccessClosure, Inc., A Cardinal Health Company Due to AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE...
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 AccessClosure, Inc., A Cardinal Health Company directly.
Affected Products
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
Quantity: 6 in USA
Why Was This Recalled?
AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. This is a deviation from the firm's standard catheterization technique.
Where Was This Sold?
This product was distributed to 2 states: FL, NJ
About AccessClosure, Inc., A Cardinal Health Company
AccessClosure, Inc., A Cardinal Health Company has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report