Events

Recall of Device Recall Flexima and Percuflex Drainage Catheter Family (Pigtail Style)

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
    51334
  • Event Risk Class
    Class 2
  • Event Number
    Z-1331-2009
  • Event Initiated Date
    2009-03-18
  • Event Date Posted
    2009-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79947
  • 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
    Suprapubic Drainage Tube - Product Code FFA
  • Reason
    Boston scientific corporation is initiating an urgent field correction related to its flexima¿ and percuflex¿ drainage catheter family (pigtail style). during the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
  • Action
    Consignees were sent a Boston Scientific " Urgent Medical Device Field Correction Notification" letter dated March 18, 2009. The letter was addressed to "The Hospital Field Action Contact". The letter described the problem, product affected and the revised catheter removal instructions. They also requested the return of the Acknowledgement Form.

Device

Device Recall Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
  • Model / Serial
    All codes
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
  • Product Description
    Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style) || UPN# DESCRIPTION || M0064101260 Percutaneous Combination Stent/Nephrostomy Catheter 8 Fr || Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. || Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
  • 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