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Flextome Cutting Balloon Device Over-the-Wire Delivery… recallZ-0621-2009 · Boston Scientific Corporation · initiated Nov 21, 2008

Terminated All recalls posted in December 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Mixed-up of materials/components

What the company is doing

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.

Recall details

Recall number
Z-0621-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 21, 2008
Posted by the FDA
Dec 24, 2008
Recalling firm
Boston Scientific Corporation
Quantity
75
Product code
LOX
FDA submissions
P950020
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.

Product description

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 (models, lots, serial numbers)

Batch/Lot # EG5577

Other devices under the same FDA submission

37 devices cleared under P950020 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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