Boston Scientific Recalls Percuflex Plus Ureteral Stent Sets Due to Tracking Issues
Boston Scientific is recalling 5 units of Percuflex Plus 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 5 units of the Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor (UPN: M006175272080). The recall affects Lot Number 24958079. 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 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 procedural delays due to the need to exchange the affected device during a medical procedure.
This is an FDA Class II recall. Healthcare providers and facilities that have received these specific stent sets should stop using the affected units and contact Boston Scientific for further instructions on the exchange or return of the devices.
The recalled product
- Product
- Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
- Manufacturer
- Boston Scientific
- Category
- Medical Device — Urological
- Affected units
- 5
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: 24958079 (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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