Recall Z-0297-2017— AccessClosure, Inc., A Cardinal Health Company

Name: FDA recall Z-0297-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-06

Class II · Terminated

Class II FDA medical device recall by AccessClosure, Inc., A Cardinal Health Company, initiated 2016-10-06, terminated 2016-11-14. It names one FDA 510(k) clearance: K143613. 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.. Reason: 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..

Recalling firm: AccessClosure, Inc., A Cardinal Health Company
Classification: Class II
Status: Terminated
Initiated: 2016-10-06
Terminated: 2016-11-14
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K143613 — PaxWire Occlusion Balloon SystemAccessclosure, Inc.·cleared 2015-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.