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.
See all 12 products in this recall →Related recalls
Same manufacturer · Boston Scientific
See all →- HighBoston Scientific Recalls Stretch VL Ureteral Stent Sets
FDA (Devices) · 2020-04-29
- ModerateBoston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues
FDA (Devices) · 2020-04-29
- ModerateBoston Scientific Recalls Percuflex Plus Ureteral Stent Sets
FDA (Devices) · 2020-04-29
- HighBoston Scientific Recalls Contour VL Ureteral Stent Sets
FDA (Devices) · 2020-04-29
- HighBoston Scientific Recalls Sensor Nitinol Wires Due to Tracking Issues
FDA (Devices) · 2020-04-29
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateBoston Scientific Recalls Flexima Duodenal Bend Biliary Stent Due to Packaging Defects
FDA (Devices) · 2019-03-20
- HighBoston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues
FDA (Devices) · 2014-01-22
- HighBoston Scientific Recalls Navigator HD Ureteral Access Sheath Sets
FDA (Devices) · 2013-12-11
- HighFDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk
FDA (Devices) · 2024-10-02
- ModerateBoston Scientific Recalls Mislabeled Ultraflex Tracheobronchial Stents
FDA (Devices) · 2016-05-04