AccessClosure, Inc., A Cardinal Health Company: Medical Device Recall in 2016 - (Recall #: Z-0297-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 6, 2016

Date Posted: November 2, 2016

Recall Number: Z-0297-2017

Event ID: 75376

Reason for Recall:

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.

Status: Terminated

Product Quantity: 6 in USA

Code Information:

Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503

Distribution Pattern:

US distribution to FL and NJ

Voluntary or Mandated:

Voluntary: Firm initiated