Boston Scientific Corp Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lots 8745076, 8745077, 8745078, 8745082, 8745083, 8764662, 8764663, 8840136, 8840210, 8888632, 8922046, 8922047, 8922048, 8925499, 8946944, 8952359, 8960112, 8991516, 9007921, 9023847, 9051903, 9063250, 9080980, 9103385, 9103712, 9103713, 9103714, 9135758, 9153911, 9160547, 9275203, 9288929, 9300199, 9303597, 9406392, 9447228, 9464347, 9484064, 9502208, 9516123, 9591056, 9629225, 9643197, 9659590, 9708545, 9727738, 9763201, 9776097, 9783671, 11001461, 11005784, 11034758, 11042785, 11091132, 11114016, 11128377, 11128379, 11178425, 11203868, 11230657, 11356155, 11403788, 11440970, 11460060, 11551315, 11580328, 11620899, 11711276, 11766589, 11851200, 11881851, 11900344, 11916630, 11931597, 11943359, 11947005, 12324021, 12450298, 12517661 and 12621268.
Products Sold
Lots 8745076, 8745077, 8745078, 8745082, 8745083, 8764662, 8764663, 8840136, 8840210, 8888632, 8922046, 8922047, 8922048, 8925499, 8946944, 8952359, 8960112, 8991516, 9007921, 9023847, 9051903, 9063250, 9080980, 9103385, 9103712, 9103713, 9103714, 9135758, 9153911, 9160547, 9275203, 9288929, 9300199, 9303597, 9406392, 9447228, 9464347, 9484064, 9502208, 9516123, 9591056, 9629225, 9643197, 9659590, 9708545, 9727738, 9763201, 9776097, 9783671, 11001461, 11005784, 11034758, 11042785, 11091132, 11114016, 11128377, 11128379, 11178425, 11203868, 11230657, 11356155, 11403788, 11440970, 11460060, 11551315, 11580328, 11620899, 11711276, 11766589, 11851200, 11881851, 11900344, 11916630, 11931597, 11943359, 11947005, 12324021, 12450298, 12517661 and 12621268.
Boston Scientific Corp is recalling Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagu due to The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
Recommended Action
Per FDA guidance
Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026