Recall Z-1542-05 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Boston Scientific Corp
Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.
| Date | Sep 14, 2005 (initiated Jul 29, 2005) |
| Status | Terminated |
| Reason | Firm has received complaints of extended ablation times, lack of roll-off and patient burns. |
| Root cause | Other |
| Action | Distributors and user accounts were notified via medical device correction letter dated 7/29/05. |
| Distribution | Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982556 | LEVEEN NEEDLE ELECTRODE Radiotherapeutics Corp., Apr 6, 2000 |