Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN; REF 26-228,
FDA device recall Z-1915-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 9,843
- 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 Zea
- Date initiated
- 2008-04-30
- Date posted
- 2008-09-11
- Date terminated
- 2009-08-04
- Location
- Spencer, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEVEEN NEEDLE ELECTRODE (K982556) | Radiotherapeutics Corp. | 2000-04-06 |