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-1333-2009
• 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; M001271540 FLEXIMA BILIARY FIRM 8F/35CM; M001271550 FLEXIMA BILIARY FIRM 10F/35CM; M001271560 FLEXIMA BILIARY REG 8F/35CM; M001271570 FLEXIMA BILIARY REG 10F/35CM; M001271580 FLEXIMA BILIARY REG 12F/35CM; M001271590 FLEXIMA BILIARY REG 14F/35CM; M001271600 FLEXIMA BILIARY SOFT 10F/35CM; M001271610 FLEXIMA BILIARY SOFT 12F/35CM; M001271620 FLEXIMA BILIARY SOFT 14F/35CM; M001281560 FLEXIMA BILIARY 8/35 TT; M001281570 FLEXIMA BILIARY 10/35 TT; M001281580 FLEXIMA BILIARY 12/35 TT; M001281590 FLEXIMA BILIARY 14/35 TT; M001271630 FLEXIMA BIL 8F/35CM FIRM KIT; M001271640 FLEXIMA BIL 10F/35CM FIRM KIT; M001271650 FLEXIMA BIL 8F/35CM REG KIT; M001271660 FLEXIMA BIL 10F/35CM REG KIT; ; 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.
• 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.