Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
This recall has been terminated (originally issued September 9, 2009).
- Company
- Boston Scientific Corp
- Recall Initiated
- July 6, 2009
- Posted
- September 9, 2009
- Terminated
- October 8, 2010
- Recall Number
- Z-1876-2009
- Quantity
- 2,774
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
Distribution
Nationwide.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.