Z-1238-06

Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm)...

Name: Z-1238-06 Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm)...
Creator: Boston Scientific Corp
Published: 2006-05-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-05-10 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent on 2006-05-10. The reason FDA records is "Instructions on how to inject are not included in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1238-06
Status: Terminated
Initiated: 2006-05-10
Posted: 2006-07-13
Terminated: 2006-11-01
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.
Product code: FAD Stent, Ureteral
Reason for recall: Instructions on how to inject are not included in the package.
Root cause tag: packaging
FDA root cause: Other
Action: A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product.
Quantity in commerce: 29
Distribution: New York and Pennsylvania.
Product codes and lots: Lot 8473180.

Product code FAD

K010002Class IIContour Polaris Ureteral StentBoston Scientific Corp / cleared 2001-01-22

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)