Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets
Boston Scientific is recalling 449 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 source describes a mechanical defect (tip separation) in a medical device without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 449 units of the Navigator HD 13F/15F x 46cm Ureteral Access Sheath Set (Product No. M0062502280, RDF Catalog M0062502290). These sterile medical devices are 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 were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.
Healthcare providers and patients should stop using the affected devices and contact Boston Scientific Corporation for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Urological
- Affected units
- 449
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 (17)
- UPN M0062502290
- Catalog 250-229
- 15579545
- 15579546
- 15615465
- 15630771
- 15630772
- 15688533
- 15688534
- 15813601
- 15823202
- 15880464
- 15927981
- 16159896
- 16175942
- 16196763
- 16373048
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.
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