Z-0621-2009

Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire...

Name: Z-0621-2009 Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire...
Creator: Boston Scientific Corporation
Published: 2008-11-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-11-21 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm... on 2008-11-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0621-2009
Status: Terminated
Initiated: 2008-11-21
Posted: 2008-12-24
Terminated: 2011-12-10
Recalling firm: Boston Scientific Corporation
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.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
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
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Batch/Lot # EG5577

Product code LOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)