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U.S. Department of Health and Human Services

Class 2 Device Recall Flextome Cutting Balloon Device OvertheWire Delivery System

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  Class 2 Device Recall Flextome Cutting Balloon Device OvertheWire Delivery System see related information
Date Initiated by Firm November 21, 2008
Date Posted December 24, 2008
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-0621-2009
Recall Event ID 50487
PMA Number P950020 
Product Classification Transluminal Coronary Angioplasty Percutaneous Catheters - Product Code LOX
Product Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland: Interventional Technologies Europe Ltd., A subsidiary of Boston Scientific Letterkenny, County Donegal, Republic of Ireland. US Customer Service 888-272-1001.

The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as Atherotomy, allows dilation of the target lesion with less pressure.

Indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered.
Code Information Batch/Lot # EG5577
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact
763-494-1700
Manufacturer Reason
for Recall		 For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Balloon device is for a 3.5mm diameter Flextome Cutting Balloon device. This labeling discrepancy could create a procedural delay as users seek to explain the discr
FDA Determined
Cause 2		 Mixed-up of materials/components
Action An Urgent medical Device Field Correction, dated November 21, 2008, was sent to affected customers/hospitals for delivery on November 24, 2008. The letter described the issue; identified product affected; use or further distribution of the affected product should be ceased immediately; and a correct compliance chart included with the notification is to be secured to the outer sterile pouch. Affected product is not asked to be returned as the correct compliance chart is enclosed and is to be secured to the outer sterile pouch. A Reply Verification Tracking Form is to be completed and faxed to Customer Service Call Center.
Quantity in Commerce 75
Distribution Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, GA, HI, ID, IL KS, MA, MD, MI, MN, MO, MS, NV, NY, OH, PA, TN, TX, UY, VA, and WI.
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.
PMA Database PMAs with Product Code = LOX and Original Applicant = Boston Scientific Corp.
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