Class 2 Device Recall Flexima and Percuflex Drainage Catheter Family (Pigtail Style)

• Date Initiated by Firm: March 18, 2009
• Date Posted: May 21, 2009
• Recall Status: Terminated on February 23, 2012
• Recall Number: Z-1332-2009
• Recall Event ID: 51334
• 510(K)Number: K944290
• Product Classification: Suprapubic Drainage Tube - Product Code FFA
• Product: Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style); ; UPN DESCRIPTION; ; M001271240 FLEXIMA APDL FIRM 10F/25CM; M001271310 FLEXIMA APDL FIRM 6.3F/25CM; M001271320 FLEXIMA APDL FIRM 8F/25CM; M001271330 FLEXIMA APDL REG 6.3F/25CM; M001271340 FLEXIMA APDL REG 8F/25CM; M001271350 FLEXIMA APDL REG 10F/25CM; M001271380 FLEXIMA APDL REG 12F/25CM; M001271390 FLEXIMA APDL REG 14F/25CM; M001271460 FLEXIMA QUICKSTICK LL 8FR; M001271470 FLEXIMA QUICKSTICK LL 10FR; M001275060 APDTL/7.3FR FLEXIMA SINGLE TT; M001275080 APDLTL/7.3FR FLEXIMA SINGLE TT; M001281340 FLEXIMA APDL 8/25 TT; M001281350 FLEXIMA APDL 10/25 TT; M001281380 FLEXIMA APDL 12/25 TT; M001281390 FLEXIMA APDL 14/25 TT; M001271960 FLEXIMA APDL 8FR REG KIT; M001271970 FLEXIMA APDL 10FR REG KIT; M001271980 FLEXIMA APDL 8FR FIRM KIT; M001271990 FLEXIMA APDL 10FR FIRM KIT; M001275070 APDTL/7.3FR FLEXIMA KIT TT; M001275010 APDLTL/7.3 FLEXIMA FIRM SINGLE; M001275090 APDLTL/7.3FR FLEXIMA KIT TT; M001275030 FLEXIMA APDLTL/7/30 STAND KIT; M001275050 FLEXIMA APDLTL/7/30 DELUXE KIT; ; Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scientific Corporation, One Boston Scientific 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.
• Code Information: All codes
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: 800-272-3737
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling False and Misleading
• 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.
• Quantity in Commerce: 586,276 US; 276,013 OUS total for all products
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FFA and Original Applicant = BOSTON SCIENTIFIC CORP.