Recall Z-0410-06 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific Corporation
The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon D
| Date | Feb 1, 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. A 100% of the total number of customer are to be contacted. |
| Quantity | individual qty in US:376, Worldwide distribution pending. |
| 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 |