FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
- Recall number
- Z-2092-2008
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile. The device is intended to be used in conjunction with a Radio Therapeutics Corporation radiofrequency (RF) generator for thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
- Status
- Terminated
- Initiated
- 2007-10-01
- Posted
- 2008-09-16
- Terminated
- 2008-09-16
- 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
- Customer notifications were sent to customers in Japan on October 1, 2007 instructing them to check their inventory and to return affected product. Contact Rob Miragliuolo at 508-683-4186 if you have questions.
- Quantity
- 15,604 of all products
- Distribution
- Japan.
- Lot, serial or model codes
- All lots.
- 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