Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Boston Scientific Corp
- Recall Initiated
- October 1, 2007
- Posted
- September 16, 2008
- Terminated
- September 16, 2008
- Recall Number
- Z-2092-2008
- Quantity
- 15,604 of all products
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
Distribution
Japan.
Lot / Code Info
All lots.
Root Cause
Device Design
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.
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