Z-1444-04

Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404...

Name: Z-1444-04 Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404...
Creator: Boston Scientific Corporation
Published: 2004-08-09
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-08-09 / Terminated

FDA source

Boston Scientific Corporation began a recall of Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material #M001404041 (10 per box). Firm on label... on 2004-08-09. The reason FDA records is "Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1444-04
Status: Terminated
Initiated: 2004-08-09
Posted: 2004-09-14
Terminated: 2005-10-26
Recalling firm: Boston Scientific Corporation
Product: Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material #M001404041 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 02472.
Product code: KNW Instrument, Biopsy
Reason for recall: Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
FDA 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 in commerce: 22 cartons x 10 units
Distribution: Products sold to 53 medical facilities nationwide and one consignee in Italy.
Product codes and lots: 6528003, 6577339

Product code KNW

K840033Class IIHypodermic Needles & StyletsMicrovasive / cleared 1984-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)