Events

Recall of PAXWIRE Occlusion Balloon System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AccessClosure, Inc., A Cardinal Health Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75376
  • Event Risk Class
    Class 2
  • Event Number
    Z-0297-2017
  • Event Initiated Date
    2016-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150167
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, intravascular occluding, temporary - Product Code MJN
  • 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.
  • 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.

Device

PAXWIRE Occlusion Balloon System
  • Model / Serial
    Product Model ACX101, Manufacturer UDI *+ M465ACX10106*  Lot No: F1614503
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to FL and NJ
  • 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.
  • Manufacturer
    AccessClosure, Inc., A Cardinal Health Company

Manufacturer

AccessClosure, Inc., A Cardinal Health Company
  • Manufacturer Address
    AccessClosure, Inc., A Cardinal Health Company, 5452 Betsy Ross Dr, Santa Clara CA 95054-1101
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA