Events

Recall of Device Recall PTA Balloon Dilatation Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Peripheral Vascular Inc.

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
    65395
  • Event Risk Class
    Class 2
  • Event Number
    Z-1533-2013
  • Event Initiated Date
    2013-05-28
  • Event Date Posted
    2013-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118770
  • 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, percutaneous - Product Code DQY
  • Reason
    Bard peripheral vascular (bpv) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. all other product labeling is consistent with the actual 8mm x 4cm balloon size.
  • Action
    BARD sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated May 30, 2013 via FedEx overnight with proof of delivery notice to all affected customers. The letter identified the affected product, reason for recall, actions to be taken, and contact information. Customers were instructed to complete the enclosed Recall and Effectivenss Check Form and fax to the attention of Recall Coordinator in Customer Service at 1-800-994-6772.

Device

Device Recall PTA Balloon Dilatation Catheters
  • Model / Serial
    Product Codes and Lot Numbers, respectively:  VA8084R, 93JW0056 VA8084, 937W0090
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. || Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess¿ PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA