Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No… — Class II medical device recall Z-0442-2014
Terminated recall by Boston Scientific Corporation, reported 2013-12-11, distributed nationwide. The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip
| Recall number | Z-0442-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2013-11-05 |
| Classified | 2013-12-04 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2014-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, DK, FR, GB, IE, IT, NL, ZA |
| Quantity | 449 |
| Model numbers | 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048, 250-229, M0062502290 |
Product
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0442-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.