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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
see related information
Date Posted May 21, 2009
Recall Status1 Open
Recall Number Z-1336-2009
Recall Event ID 51334
Premarket Notification
510(K) Numbers
K023870  K811378  K820867  K900205  K944290 
Product Classification Catheter, Biliary, Diagnostic - Product Code FGE
Product Boston Scientific, Flexima® and Percuflex® Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001201050 VSKCL-12 M001201060 VSKCL-14 M001202020 VSDCL-12 M001202030 VSDCL-14 M001203060 VSCL-12 M001203070 VSCL-14 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 Product 8 All codes
Recalling Firm/
Manufacturer
Boston Scientific Corporation
1 Scimed Pl
Maple Grove, Minnesota 55311-1565
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 2
MISBRANDING: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP.
510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC/MEDI-TECH
510(K)s with Product Code = FGE and Original Applicant = MEDI-TECH, INC.
510(K)s with Product Code = FGE and Original Applicant = VAN-TEC, INC.
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