Z-0759-04

VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga...

Name: Z-0759-04 VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga...
Creator: Boston Scientific Corporation
Published: 2004-03-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-03-05 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm... on 2004-03-05. The reason FDA records is "Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0759-04
Status: Terminated
Initiated: 2004-03-05
Posted: 2004-07-20
Terminated: 2005-10-26
Recalling firm: Boston Scientific Corporation
Product: VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston Scientific.
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
Reason for recall: Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letter dated 3/5/04 with instructions to return product.
Quantity in commerce: 75 units (box/10)
Distribution: 42 domestic hospitals nationwide and one distributor in Canada.
Product codes and lots: 912502, Exp. 10/31/05

Product code DRE

K974640Class IICoaxial Dilator SetBoston Scientific Corp / cleared 1998-03-13

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)