Recall Z-0409-06 ยท MCX Catheter, Coronary, Atherectomy
Boston Scientific Corporation
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 AtherotomyQ3J, allows dilatation of the target lesion with less pressure. The device
| Date | Jan 31, 2006 (initiated Dec 7, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | All affected direct accounts will be given notification by Overnight mail 1/26/2006. 100% of the total number of customers are to be contacted. |
| Quantity | qty in US:25,311 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052038 | PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM Boston Scientific Corporation, Aug 16, 2005 |