BEUDAMED
    FDA Recall Terminated

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001272600 FLEXIMA BILIARY REG RO 8F/35CM M001272610 FLEXIMA BILIARY REG RO 10F/35CM M001272620 FLEXIMA BILIARY REG RO 12F/35CM M001272630 FLEXIMA BILIARY REG RO 14F/35CM M001272640 FLEXIMA BILIARY FIRM RO 8F/35CM M001272650 FLEXIMA BILIARY FIRM RO 10F/35CM M001272660 FLEXIMA BILIARY SOFT RO 10F/35CM M001272670 FLEXIMA BILIARY SOFT RO 12F/35CM M001282600 FLEXIMA BILIARY TT RO 8F/35CM M001282610 FLEXIMA BILIARY TT RO 10F/35CM 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.

    Recall: Z-1337-2009 · Initiated March 18, 2009

    Recall

    Recall Number
    Z-1337-2009
    Event Number
    51334
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 18, 2009
    Posted
    May 21, 2009
    Terminated
    February 23, 2012
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001272600 FLEXIMA BILIARY REG RO 8F/35CM M001272610 FLEXIMA BILIARY REG RO 10F/35CM M001272620 FLEXIMA BILIARY REG RO 12F/35CM M001272630 FLEXIMA BILIARY REG RO 14F/35CM M001272640 FLEXIMA BILIARY FIRM RO 8F/35CM M001272650 FLEXIMA BILIARY FIRM RO 10F/35CM M001272660 FLEXIMA BILIARY SOFT RO 10F/35CM M001272670 FLEXIMA BILIARY SOFT RO 12F/35CM M001282600 FLEXIMA BILIARY TT RO 8F/35CM M001282610 FLEXIMA BILIARY TT RO 10F/35CM 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.

    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.

    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.

    Quantity

    586,276 US; 276,013 OUS total for all products