AccessClosure Recalls PAXWIRE Occlusion Balloon System Due to Removal Risk
AccessClosure, Inc. is voluntarily recalling the PAXWIRE Occlusion Balloon System because the device may be removed without a vascular sheath in place.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a deviation from standard technique that poses a risk of harm, but no injuries or illnesses have been reported.
Plain-English summary
AccessClosure, Inc. (ACI), a Cardinal Health company, is voluntarily recalling the PAXWIRE Occlusion Balloon System. This medical device consists of an occlusion catheter, inflation handle, and syringes, and is designed for use in the iliofemoral artery to provide temporary occlusion during catheterization procedures.
The recall was initiated after the company learned from customers that the device may be removed in the absence of a vascular sheath across the arteriotomy. This scenario represents a deviation from the firm's standard catheterization technique.
The recall affects six units of the PAXWIRE Occlusion Balloon System (Model ACX101, Lot No: F1614503) distributed in the United States to Florida and New Jersey. Healthcare facilities and users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 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 cathete
- Manufacturer
- AccessClosure, Inc., A Cardinal Health Company
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Model ACX101
- Manufacturer UDI *+ M465ACX10106* Lot No: F1614503
Distribution
Related recalls
Same manufacturer · AccessClosure, Inc., A Cardinal Health Company
See all →- ModerateAccessClosure Recalls MynxGrip Vascular Closure Devices Due to Packaging Errors
FDA (Devices) · 2016-08-10
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See all →- SevereNewDeal UNI-CP Medical Devices Recalled Due to Infection Risk
FDA (Devices) · 2018-07-25
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