Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets
Boston Scientific is recalling Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard involves a mechanical failure (tip separation) in a medical device used in the urinary tract, which poses a risk of harm, but the source text does not report specific injuries or illnesses.
Plain-English summary
Boston Scientific Corporation is recalling 939 units of the Navigator HD 13F/15F x 36cm Ureteral Access Sheath Set. The product is 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 where the tip of the dilator separated from the body of the dilator. The affected units are sterile and were distributed worldwide, including the United States (nationwide), Puerto Rico, Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Netherlands.
Healthcare providers and patients should stop using the affected product immediately. The specific lot numbers involved are 15753725, 15819257, 15840833, 1587719, 15918445, 15931128, 16008343, 16015286, 16065866, 16141201, 16295107, and 16319657. The product number is M0062502280 and the RDF Catalog number is 250-228.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 939
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 M0062502280
- Catalog 250-228
- Lot 15753725
- 15819257
- 15840833
- 1587719
- 15918445
- 15931128
- 16008343
- 16015286
- 16065866
- 16141201
- 16295107
- 16319657
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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