FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material #M001406001 (5 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
- Recall number
- Z-1445-04
- Recalling firm
- Boston Scientific Corporation
- Product
- Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material #M001406001 (5 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
- Status
- Terminated
- Initiated
- 2004-08-09
- Posted
- 2004-09-14
- Terminated
- 2005-10-26
- Reason
- Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Root cause
- Other
- Action
- Letters dated 8/9/04 hand delivered by Boston Scientific Sales Representatives. Sales Reps will visit each consignee and assist customers in locating affected units and will place a sticker label on each unit.
- Quantity
- 27 cartons x 5 units
- Distribution
- Products sold to 53 medical facilities nationwide and one consignee in Italy.
- Lot, serial or model codes
- 6528009
- 510(k) numbers
- ["K840033"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3001451463
- Firm city
- Natick
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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