Z-1106-04

Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and...

Name: Z-1106-04 Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and...
Creator: Boston Scientific Corp
Published: 2004-06-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-06-25 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corp began a recall of Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap... on 2004-06-25. The reason FDA records is "Mislabeled as to size; 10FR are labeled as 8FR". 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-1106-04
Status: Terminated
Initiated: 2004-06-25
Posted: 2004-07-20
Terminated: 2004-08-23
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.
Product code: GBO Catheter, Nephrostomy, General & Plastic Surgery
Reason for recall: Mislabeled as to size; 10FR are labeled as 8FR.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm hand delivered the recall notification to the consignee hospital on 6/30/04. Product at the customer have been relabeled by the firm.
Distribution: Missouri.
Product codes and lots: Lots 6030323, exp. 01-Nov-06; 6348004, exp. 01-Mar-07 and 6313957, exp 01-Mar-07.

Product code GBO

K820867Class IPercutaneous Nephrostomy SetVan-Tec, Inc. / cleared 1982-04-13

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)