FDAOctober 6, 2016device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
accessclosure inc a cardinal healthaccessclosureaccessclosure inc
Recall history
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