Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets
Boston Scientific is recalling 32 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a procedural delay and the need to exchange the device, but does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific is recalling 32 units of the Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor (UPN: M006175263110). The recall is limited to Lot Number 24835477. The affected devices were distributed nationwide and in foreign regions including Europe, the Middle East, 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 the device over the guidewire. This issue may result in a procedural delay due to the need to exchange the affected device during the procedure.
Healthcare providers and facilities that have received these specific stent sets should stop using them and contact Boston Scientific for further instructions on how to manage the affected inventory.
The recalled product
- Product
- Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
- Manufacturer
- Boston Scientific
- Affected units
- 32
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 Number: 24835477 (edited 1/13/2021)
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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