Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 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.
FDA Recall Z-2094-2008 · Posted 2008-09-16
Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-10-01
Date Terminated2008-09-16
Product Quantity15,604 of all products
Reason for Recall
The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
Firm Action
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
Distribution Pattern
Japan.
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.