AccessClosure, Inc., A Cardinal Health Company recalls The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed f…

Recall date

October 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0297-2017

FDA classification

Class II

Brand / firm

AccessClosure, Inc., A Cardinal Health Company

Sold / distributed

US distribution to FL and NJ

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.