FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-229, UPN M001262290. The product is used with radiofrequency generator for the thermal coagulation necrosis of soft tissues,including partial or complete ablation of nonresectable liver lesions.
- Recall number
- Z-1916-2008
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-229, UPN M001262290. The product is used with radiofrequency generator for the thermal coagulation necrosis of soft tissues,including partial or complete ablation of nonresectable liver lesions.
- Status
- Terminated
- Initiated
- 2008-04-30
- Posted
- 2008-09-11
- Terminated
- 2009-08-04
- Reason
- The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Root cause
- Device Design
- 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.
- Quantity
- 2,307
- Distribution
- 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.
- Lot, serial or model codes
- Lots 8382, 0007772112, 0007799189, 0007810726, 0007873053, 0007916555, 0008034686, 0008123319, 0008135736, 0008135737, 0008144857, 0008147541, 0008185484, 0008189884, 0008206704, 0008271342, 0008396414, 0008428150, 0008470440, 0008546755, 0008625282, 0008815837, 0008839480, 0008845098, 0008865219, 0008870962, 0008891504, 0008971484, 0009070215, 0009080832, 0009107193, 0009125675, 0009137173, 0009154346, 0009160546, 0009299951, 0009303596, 0009333564, 0009385351, 0009429552, 0009446553, 0009457083, 0009488650, 0009498166, 0009564539, 0009569175, 0009606078, 0009623181, 0009647789, 0009663658, 0009711987, 0009734050, 0009750637, 0009783670, 0009800137, 0009802809, 0011038755, 0011299942 and 0011311215.
- 510(k) numbers
- ["K982556"]
- 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