Z-0441-2014Class II

Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228...

Name: Z-0441-2014 Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228...
Creator: Boston Scientific Corporation
Published: 2013-11-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-11-05 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to... on 2013-11-05. FDA classified it as Class II and gives the reason as "The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0441-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-05
Posted: 2013-12-04
Terminated: 2014-12-08
Recalling firm: Boston Scientific Corporation
Product: Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Product code: FED Endoscopic Access Overtube, Gastroenterology-Urology
Reason for recall: The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
Root cause tag: design
FDA root cause: Component design/selection
Action: Urgent recall notification letters were sent via Federal Express Priority mail on November 5, 2013. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.
Quantity in commerce: 939
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.
Product codes and lots: UPN M0062502280, Catalog 250-228, Lot 15753725,15819257,15840833,1587719, 15918445,15931128, 16008343,16015286, 16065866,16141201, 16295107,16319657

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0441-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0440-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04
Z-0441-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04
Z-0442-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04

Product code FED

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)