Events

Recall of Device Recall Fathom"14 Steerable Guidewire Peripheral Vascular Use, 200 cm x 10 cm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

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
    56059
  • Event Risk Class
    Class 2
  • Event Number
    Z-2068-2010
  • Event Initiated Date
    2010-06-03
  • Event Date Posted
    2010-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92560
  • 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
    Wire, guide, catheter - Product Code DQX
  • Reason
    Boston scientific is initiating a medical device recall regarding specific lots of the fathomtm-14 steerable guidewire. for lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (ptfe). through internal inspection process, the firm determined that fathom guidewires from affected lots may exhibit a p.
  • Action
    Consignees were sent on 6/3/10 an "Urgent Medical Device Recall" letter dated 3 June 2010. The letter was addressed to Risk Manger/Interventional Radiology Manger/Material Manger. The letter described the problem and the product involved. The letter included the "Customer Instructions" which stated to Immediately discontinue use of an segregate recalled product and, requested customers to return the Reply Verification Tracking Form. Questions are directed to the firm at 510-624-2563.

Device

Device Recall Fathom"14 Steerable Guidewire Peripheral Vascular Use, 200 cm x 10 cm
  • Model / Serial
    B17404, B18118, B18485, B18595, B18702, B18746
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AR, CA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MD, MA, MS, NV, NY, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT,VA, WA, WT.
  • Product Description
    Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 USA.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA