Events

Recall of Device Recall Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps

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
    55740
  • Event Risk Class
    Class 2
  • Event Number
    Z-1774-2010
  • Event Initiated Date
    2010-05-06
  • Event Date Posted
    2010-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91770
  • 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
    Forceps, biopsy, non-electric - Product Code FCL
  • Reason
    Clevis may detach from the coil preventing the device to open and/or close. delays in the procedure may result.
  • Action
    Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. In the letter, customers with questions are provided with a phone and email at the firm to contact.

Device

Device Recall Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps
  • Model / Serial
    Lot: 13244654
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide; Panama.
  • Product Description
    Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps || UPN/Catalog Number: MOO513330 || The Radial Jaw 4 Large Capacity Inner Pouch, 240cm UPN M00513330 is a single unit which is packaged into a Box of 20 units (UPN M00513331), and a Box of 80 units (UPN M00513334). || Single packaged units of M00513330 are not sold individually.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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