Recall Z-0297-2017 ยท MJN Catheter, Intravascular Occluding, Temporary
AccessClosure, Inc., A Cardinal Health Company
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.
| Date | Oct 6, 2016 |
| Status | Terminated |
| 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. |
| 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 instruct |
| Quantity | 6 in USA |
| Distribution | US distribution to FL and NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143613 | PaxWire Occlusion Balloon System Accessclosure, Inc., Aug 14, 2015 |