FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
- Recall number
- Z-0080-2013
- Recalling firm
- Boston Scientific Corporation
- Product
- Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
- Status
- Terminated
- Initiated
- 2012-09-17
- Posted
- 2012-10-18
- Terminated
- 2013-07-17
- Reason
- Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.
- Root cause
- Labeling Change Control
- Action
- Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.
- Quantity
- 19,716 units distributed total
- Distribution
- Distributed in Brazil, Portugal and Hong Kong.
- Lot, serial or model codes
- Material Catalog Number: MOO1262230 with lot numbers: 12293473, 12580337, 12639146, 12639181, 12642715,12647752,12651931,12653869, 12656587, 12663028, 12663626, 12667129, 12667787, 12741165, 12760565, 12799352, 12825090, 12849385, 12860811, 12895401, 12967872, 13002918, 13058416, 13096459, 13120668, 13166239, 13235239, 13309477, 13383272, 13399503, 13418415, 13463515, 13498936, 13545732, 13559348, 13665665, 13775008, 13805295, 13822358, 13872667, 13902427, 14076298, 14119776, 14131133, 14169885, 14206936, 14279112, and 14288333. Material Catalog Number: MOO1262240 with lot numbers: 12341198, 12341781, 12348901, 12351784, 12533460,12533461,12533466,12533467, 12533468, 12600849, 12642716, 12651932, 12663627, 12663628, 12663629, 12667788, 12674036, 12674312, 12741166, 12771577, 12805833, 12805835, 12860812, 12876589, 12937149, 12953904, 12982469, 13020096, 13048075, 13075112, 13117330, 13169619, 13230606,13247208, 13254418, 13278009, 13299117, 13309317, 13352191, 13384075, 13415014,13476371, 13480767, 13545557, 13592399, 13605018, 13610851, 13677260, 13727387,13775007, 13798432, 13813580, 13822357,13837691, 13873878, 13875213, 13883193, 13883196, 13936544, 13940480, 13978762,14076299, 14096255, 14157926, 14169886,14169887, 14217955, and 14249334.
- 510(k) numbers
- ["K012315"]
- PMA numbers
- not on file
- Product code
- JOS
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- 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