Recall Z-2094-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
| Date | Sep 16, 2008 (initiated Oct 1, 2007) |
| Status | Terminated |
| Reason | The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines. |
| Root cause | Device Design |
| Action | Customer notifications were sent to customers in Japan on October 1, 2007 instructing them to check their inventory and to return affected product. Contact Rob Miragliuolo at 508-683-4186 if you have questions. |
| Quantity | 15,604 of all products |
| Distribution | Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982556 | LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp., Apr 6, 2000 |