Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device is intended to be used in conjunc
FDA device recall Z-2091-2008 · posted 2008-09-16 · 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
- Customer notifications were sent to customers in Japan on October 1, 2007 instructing them to check their inventory and to return affected product. Contact Rob Miragliuolo at 508-683-4186 if you have questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 15,604 of all products
- Distribution
- Japan.
- Date initiated
- 2007-10-01
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-16
- Location
- Spencer, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEVEEN NEEDLE ELECTRODE (K982556) | Radiotherapeutics Corp. | 2000-04-06 |