Boston Scientific Recalls Polaris Ultra Ureteral Stent Sets
Boston Scientific is recalling 19 Polaris Ultra 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. The hazard involves a procedural delay due to device malfunction, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific is recalling 19 units of the Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor (UPN: M006192132080). The affected units are identified by lot numbers 24749818 and 24913418. The recall was initiated due to an increase in the rate of complaints regarding difficulty or inability to track the device over the guidewire.
The affected devices were distributed nationwide and internationally to Europe, the Middle East and Africa, the Americas (North and South America), Asia Pacific, and Japan. The source text does not specify specific dates of distribution or the exact number of units distributed in each region.
Healthcare providers and facilities should stop using the affected devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences. No specific instructions for consumers are provided in the source text, as the product is a medical device intended for professional use.
The recalled product
- Product
- Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
- Manufacturer
- Boston Scientific
- Category
- Medical Device — Urological
- Affected units
- 19
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: 24749818
- 24913418
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
- HighBoston Scientific Recalls Navigator HD Ureteral Access Sheath Sets
FDA (Devices) · 2013-12-11
- HighBoston Scientific Recalls Contour VL Ureteral Stents Due to Nickel Debris
FDA (Devices) · 2021-01-06
- HighBoston Scientific Recalls Contour VL Ureteral Stent Sets Due to Nickel Debris
FDA (Devices) · 2021-01-06
- ModerateBoston Scientific Recalls Flexima Duodenal Bend Biliary Stent Due to Packaging Defects
FDA (Devices) · 2019-03-20
- HighBoston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues
FDA (Devices) · 2014-01-22
- CriticalAXIOS 6mm stents recalled over deployment and expansion problems
FDA (Devices) · 2026-02-11