Events

Recall of Device Recall Boston Scientific PLUS

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
    66907
  • Event Risk Class
    Class 2
  • Event Number
    Z-0721-2014
  • Event Initiated Date
    2013-11-20
  • Event Date Posted
    2014-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124141
  • 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
    Snare, non-electrical - Product Code FGX
  • Reason
    Sterility of device may be compromised due to lack of pouch seal integrity.
  • Action
    Boston Scientific issued Customer Notification letters to US accounts via Federal Express Priority mail on November 20, 2013. 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.

Device

Device Recall Boston Scientific PLUS
  • Model / Serial
    Lot Numbers: H13061101, H13062403, H13062404, H13071301
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, Australia, New Zealand, France, Spain, Portugal, Italy, Switzerland, Denmark, and Netherlands.
  • Product Description
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) || Universal Product Number (UPN):M00561412. || Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica || Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
  • 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