Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets
Boston Scientific is recalling 274 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device used in invasive procedures where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 274 units of the Navigator HD 13F/15F x 28 cm Ureteral Access Sheath Set. The product is sterile and indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments, and for the injection of fluids into the urinary tract.
The recall was initiated after the company received five reports that the tip of the dilator separated from the body of the dilator. The affected units are identified by Product No M0062502270, RDF Catalog No 250-227, and specific lot numbers including 15708431, 15708432, 15708433, 15812875, 15836355, 15855545, 15876213, 15896950, 15935564, 16028474, 16044445, and 16046280.
The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands. Healthcare providers and facilities should stop using the affected devices and contact Boston Scientific for further instructions.
The recalled product
- Product
- Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, 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.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 274
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- UPN M0062502270
- Catalog 250-227
- Lot 15708431
- 15708432
- 15708433
- 15812875
- 15836355
- 15855545
- 15876213
- 15896950
- 15935564
- 16028474
- 16044445
- and 16046280
Distribution
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · structural defect
See all →- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- HighLight Boy Recalls GBX12SK Light Towers Due to Frame Bending Risk
NHTSA · 2026-09-01
- SevereKmaier Infant Walkers Recalled for Serious Fall Hazard
CPSC · 2026-08-27
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- SevereFord Recalls 2026 Maverick, F-150, and Bronco Sport for Joint Issues
NHTSA · 2026-08-25