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U.S. Department of Health and Human Services

Class 2 Device Recall PAXWIRE Occlusion Balloon System

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 Class 2 Device Recall PAXWIRE Occlusion Balloon Systemsee related information
Date Initiated by FirmOctober 06, 2016
Create DateOctober 21, 2016
Recall Status1 Terminated 3 on November 14, 2016
Recall NumberZ-0297-2017
Recall Event ID 75376
510(K)NumberK143613 
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
ProductThe 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.
Code Information Product Model ACX101, Manufacturer UDI *+ M465ACX10106*  Lot No: F1614503  
FEI Number 3010142363
Recalling Firm/
Manufacturer		 AccessClosure, Inc., A Cardinal Health Company
5452 Betsy Ross Dr
Santa Clara CA 95054-1101
For Additional Information ContactDoniell Baudin
408-610-6500
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionCardinal 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 Commerce6 in USA
DistributionUS distribution to FL and NJ
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = MJN
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