Boston Scientific Corporation 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. Wh Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.