Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets
Boston Scientific is recalling 91 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.
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 procedural delay and device exchange, which represents a risk of harm where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Boston Scientific is voluntarily recalling 91 units of the Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor (UPN: M006175262110). The recall affects Lot Number 24795838. The devices were distributed nationwide and in foreign regions including Europe, the Middle East and Africa, the Americas, Asia Pacific, and Japan.
The recall was initiated due to an increase in the rate of complaints regarding difficulty or inability to track over the guidewire. This issue may result in a procedural delay due to the need to exchange the affected device during a medical procedure.
Healthcare providers and facilities that have received these devices should stop using them and contact Boston Scientific for further instructions. Patients who have had these devices implanted should contact their healthcare provider to discuss the recall and any necessary follow-up care.
The recalled product
- Product
- Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
- Manufacturer
- Boston Scientific
- Category
- Medical Device — Urological
- Affected units
- 91
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 (1)
- Lot Numbers: 24795838
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.
See all 12 products in this recall →Related recalls
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