Recall Z-1916-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Boston Scientific Corp
Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-229, UPN M001262290. The product is used with radiofrequency generator for the thermal coagulation necrosis of soft tissues,including partial or complete ablation of nonresectable liver lesions.
| Date | Sep 11, 2008 (initiated Apr 30, 2008) |
| 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 | Consignees were notified by recall letter on 4/30/08, sent fexex priority mail, to cease use of the products and to return them to the firm. For assistance, contact Boston Scientific at 1-508-683-4186. |
| Quantity | 2,307 |
| Distribution | Nationwide, Argentina, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Iraq, Ireland, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, and United |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982556 | LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp., Apr 6, 2000 |