FDA Device recall Z-0442-2014
Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile
- FDA Device
- Class II
- terminated
- Published 2013-12-11
On 2013-12-11 the FDA classified a Class II recall of Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0442-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-05 |
| Published | 2013-12-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
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.
Identifiers
| code_info | UPN M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601,…UPN M0062502290, Catalog 250-229, 15579545, 15579546, 15615465, 15630771, 15630772, 15688533, 15688534, 15813601, 15823202, 15880464, 15927981, 16159896, 16175942, 16196763, 16373048, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0442-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.