Boston Scientific Recalls Contour VL Ureteral Stent Sets
Boston Scientific is recalling Contour VL Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
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 and involves a risk-of-harm product (medical device) where the hazard is procedural delay and device exchange, but no injuries or illnesses have been reported.
Plain-English summary
Boston Scientific is voluntarily recalling 2 units of the Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor (UPN: M006180156080). The recall affects specific lot numbers 24879999 and 25021676. The devices were distributed nationwide and in foreign regions including Europe, the Middle East, Africa, the Americas, Asia Pacific, and Japan.
The recall was initiated because of an increase in the rate of complaints regarding difficulty or inability to track the device over the guidewire. This issue may result in procedural delays due to the need to exchange the affected device during a medical procedure.
Healthcare providers and facilities should stop using the affected devices and contact Boston Scientific for further instructions on the recall process.
The recalled product
- Product
- Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
- Manufacturer
- Boston Scientific
- Category
- Medical Device — Urological
- Affected units
- 2
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 (2)
- Lot Numbers: 24879999
- 25021676
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Boston Scientific 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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