Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile, Boston Scientific, Spencer, IN; REF 26-226, UPN M001262260. The product is used with a radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
FDA Recall Z-1913-2008 · Posted 2008-09-11
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-04-30
Date Terminated2009-08-04
Product Quantity7,460
Reason for Recall
The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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