Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216.
FDA device recall Z-1541-05 · posted 2005-09-14 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
- Action taken
- Distributors and user accounts were notified via medical device correction letter dated 7/29/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Distribution
- Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan.
- Date initiated
- 2005-07-29
- Date posted
- 2005-09-14
- Date terminated
- 2005-12-08
- Location
- Spencer, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEVEEN NEEDLE ELECTRODE (K982556) | Radiotherapeutics Corp. | 2000-04-06 |