Device brand name · Stent ureteral
Polaris? Loop: medical device reports filed with FDA
154 reports name it, 2012–2026. Manufacturer given most often on reports: Boston Scientific. Product code FAD.
- 154
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 25
- reports, 12 months to August 2026
- 25 in the 12 months before
- 93.5%
- classified as malfunction
- 70.6% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
154 medical device reports received by FDA name the brand "Polaris? Loop" (stent ureteral); the manufacturer given most often on reports is Boston Scientific; received from March 2012 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
25 reports arrived in the 12 months to August 2026, close to the 25 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (93.5%), injury (5.8%) and death (0.6%); across all stent, ureteral reports (product code FAD) death is recorded in 0.2% and malfunction in 70.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (37%), material split, cut or torn (15.6%) and detachment of device or device component (11.7%). The patient problems coded most often are pain, discomfort and hematuria. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,909 reports carrying product code FAD. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 57 | 37% | 24.1% |
| Material split, cut or torn | 24 | 15.6% | 3.9% |
| Detachment of device or device componentpart of the device came off | 18 | 11.7% | 3.6% |
| Difficult to advance | 13 | 8.4% | 3.6% |
| Material deformation | 11 | 7.1% | 3.4% |
| Calcified | 8 | 5.2% | 8% |
| Deformation due to compressive stress | 8 | 5.2% | 2.8% |
| Difficult to removethe device was hard to remove | 6 | 3.9% | 6.8% |
| Defective devicethe device was defective | 3 | 1.9% | 0.4% |
| Device contamination with chemical or other material | 3 | 1.9% | 0.6% |
| Material integrity problema problem with the device material | 3 | 1.9% | 0.7% |
| Migrationthe device moved from where it was placed | 3 | 1.9% | 2.9% |
| Nonstandard device | 3 | 1.9% | 1.2% |
| Device contaminated during manufacture or shipping | 2 | 1.3% | 0.4% |
| Device stenosis | 1 | 0.6% | 0.4% |
| Device-device incompatibility | 1 | 0.6% | 0.3% |
| Obstruction of flow | 1 | 0.6% | 0.7% |
| Packaging problem | 1 | 0.6% | 0.2% |
| Unsealed device packaging | 1 | 0.6% | 0.9% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 3 | 1.9% |
| Discomfortdiscomfort | 1 | 0.6% |
| Hematuria | 1 | 0.6% |
| Obstruction/occlusion | 1 | 0.6% |
| Swelling/ edema | 1 | 0.6% |
| Urinary tract infectionbladder or urinary infection | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Polaris? Loop | Product code FAD | All MAUDE reports |
|---|---|---|---|
| Reports | 154 | 5,909 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 6 | 2 | 9 |
| Classified as injury | 5.8% | 28.5% | 36.2% |
| Classified as malfunction | 93.5% | 70.6% | 62.3% |
| Filed by the manufacturer | 100% | 94.5% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FAD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Polaris? Ultra | 478 | 49 | 0% |
| Bard InLay Optima Ureteral Stent | 394 | 44 | 0% |
| Bard InLay Ureteral Stent with HydroGlide Guidewire | 342 | 17 | 0% |
| Percuflex Plus | 458 | 50 | 0.4% |
| Resonance Stent Set | 256 | 16 | 1.2% |
| Bard InLay Ureteral Stent | 232 | 25 | 0% |
| Filiform Double Pigtail Ureteral Stent Set | 227 | 38 | 0.4% |
| Bard InLay Optima Ureteral Stent with HydroGlide Guidewire | 220 | 14 | 0% |
| Universa Soft Ureteral Stent Set | 205 | 14 | 0% |
| Universa Firm Ureteral Stent Set | 203 | 12 | 0% |
| Contour | 2,235 | 38 | 0% |
| Flexima? | 257 | 10 | 0.4% |
| Boston Scientific | 580 | 5 | 3.3% |
| Cotton-Leung Biliary Stent | 271 | 20 | 1.1% |
| Cook | 271 | 6 | 2.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Polaris? Loop reports
How many FDA reports name Polaris? Loop?
154 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 25 in the latest 12 months.
What kinds of events are reported?
malfunction (93.5%), injury (5.8%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (37%), material split, cut or torn (15.6%), detachment of device or device component (11.7%), difficult to advance (8.4%) and material deformation (7.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Polaris? Loop was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.