Recall Z-1876-2009 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Boston Scientific Corp
Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
| Date | Sep 9, 2009 (initiated Jul 6, 2009) |
| Status | Terminated |
| Reason | The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention. |
| Root cause | Process control |
| Action | Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form. |
| Quantity | 2,774 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000032 | LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp., Mar 30, 2000 |