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AccessClosure, Inc., A Cardinal Health Company recalls The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed fo
Recalled November 2, 2016 · FDA recall Z-0297-2017 · AccessClosure, Inc., A Cardinal Health
Hazard
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. · FDA Class II
Units
6 in USA
Sold at
US distribution to FL and NJ
Description
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.
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 catheterization procedures.
Manufacturer(s)
AccessClosure, Inc., A Cardinal Health Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →