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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Peripheral Cutting Balloon Microsurgical Dilatation Device small Monorail Delivery System see related information
Date Initiated by Firm December 07, 2005
Date Posted February 01, 2006
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Boston Scientific Corporation
PMA Database PMAs with Product Code = LIT and Original Applicant = Boston Scientific Corp.
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