Class 2 Device Recall Peripheral Cutting Balloon Microsurgical Dilatation Device small Monorail Delivery System

• Date Initiated by Firm: December 07, 2005
• Date Posted: February 01, 2006
• Recall Status: Terminated on August 10, 2007
• Recall Number: Z-0410-06
• Recall Event ID: 34504
• 510(K)Number: K052038
• PMA Number: P950020
• Product Classification: Catheter, Angioplasty, Peripheral, Transluminal - Product Code LIT
• Product: The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.
• Code Information: Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 3574 Ruffin Rd; San Diego CA 92123-2597
• For Additional Information Contact: Abe Mathews; 408-895-3981
• Manufacturer Reason for Recall: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
• FDA Determined Cause: Other
• Action: All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.
• Quantity in Commerce: individual qty in US:376, Worldwide distribution pending.
• Distribution: Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain Sweden Switzerland & Turkey
• 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 = LIT
• PMA Database: PMAs with Product Code = LIT