Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation.
FDA device recall Z-1877-2009 · posted 2009-09-09 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 347
- Distribution
- Nationwide.
- Date initiated
- 2009-07-06
- Date posted
- 2009-09-09
- Date terminated
- 2010-10-08
- Location
- Spencer, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEVEEN NEEDLE ELECTRODE (K000032) | Radiotherapeutics Corp. | 2000-03-30 |