FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
- Recall number
- Z-1876-2009
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific, LeVeen Needle Electrode, 15 cm, 5.0 cm, sterile; REF M001262160. For tissue coagulation.
- Status
- Terminated
- Initiated
- 2009-07-06
- Posted
- 2009-09-09
- Terminated
- 2010-10-08
- Reason
- The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 2,774
- Distribution
- Nationwide.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K000032"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28