Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-227, UPN M001262270. The product is used with radiofrequency generator for the thermal coagulation necrosis of soft tissues,including partial or complete ablation of nonresectable liver lesions.
This recall has been terminated (originally issued September 11, 2008).
- Company
- Boston Scientific Corp
- Recall Initiated
- April 30, 2008
- Posted
- September 11, 2008
- Terminated
- August 4, 2009
- Recall Number
- Z-1914-2008
- Quantity
- 1,356
- 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
Nationwide, Argentina, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Iraq, Ireland, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Arab Emirates.
Lot / Code Info
All lots (Lots 0007754222, 0007757352, 0007774377, 0007778866, 0007787319, 0007802363, 0007819373, 0008025066, 0008033462, 0008119925, 0008126720, 0008139108, 0008167709, 0008187490, 0008189883, 0008191619, 0008272777, 0008274731, 0008301843, 0008900347, 0009106193, 0009261704, 0009261705, 0009261706, 0009275205, 0009292249, 0009344591, 0009382115, 0009422549, 0009437649, 0009446512, 0009464930, 0009505685, 0009532051, 0009569176, 0009595712, 0009647788, 0009663657, 0009749621, 0009783669, 0009799393, 0009993406 0011311216 and 0011517938.)
Root Cause
Device Design
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.