Z-0297-2017Class II

The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is...

Name: Z-0297-2017 The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is...
Creator: AccessClosure, Inc., A Cardinal Health Company
Published: 2016-10-06
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2016-10-06 / Terminated / root cause: design

FDA source

AccessClosure, Inc., A Cardinal Health Company began a recall of The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to... on 2016-10-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0297-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-06
Posted: 2016-10-21
Terminated: 2016-11-14
Recalling firm: Cordis US Corp.
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.
Product code: MJN Catheter, Intravascular Occluding, Temporary
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.
Root cause tag: design
FDA root cause: Device Design
Action: Cardinal Health sent an Urgent Medical Device Field Safety Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed complete the attached Field Action Return Response Form as soon as possible indicating the number of devices that have been used as their location and the number that will be returned. Customers should discuss the reimbursement for their purchased and return product with their sales representative, who will coordinate the process. Customers with questions were instructed to call 408-610-6570. For questions regarding this recall call 408-610-6500.
Quantity in commerce: 6 in USA
Distribution: US distribution to FL and NJ
Product codes and lots: Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0297-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0297-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-21

Product code MJN

K143613Class IIPaxWire Occlusion Balloon SystemAccessclosure, Inc. / cleared 2015-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)