Devices › Drug-coated peripheral transluminal angioplasty catheter
Device brand name · Drug coated balloon pta catheter
Lutonix 035AV Drug Coated PTA Dilation Catheter: medical device reports filed with FDA
171 reports name it, 2020–2026. Manufacturer given most often on reports: Lutonix. Product code PRC.
- 171
- device reports naming the brand
- 0% of all MAUDE reports · about 29 a year
- 16
- reports, 12 months to August 2026
- 57 in the 12 months before
- 19.3%
- classified as malfunction
- 19.4% across the product code
- 2.9%
- classified as death, as reported
- 5 reports · not verified by FDA
171 medical device reports received by FDA name the brand "Lutonix 035AV Drug Coated PTA Dilation Catheter" (drug coated balloon pta catheter); the manufacturer given most often on reports is Lutonix; received from July 2020 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
16 reports arrived in the 12 months to August 2026, down 72% from 57 in 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 injury (77.8%), malfunction (19.3%) and death (2.9%); across all drug-coated peripheral transluminal angioplasty catheter reports (product code PRC) death is recorded in 1.5% and malfunction in 19.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (6.4%), difficult to remove (4.7%) and detachment of device or device component (4.1%). The patient problems coded most often are restenosis, hemorrhage/blood loss/bleeding and thrombosis/thrombus. 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 536 reports carrying product code PRC. 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 |
|---|---|---|---|
| Material rupture | 11 | 6.4% | 6.2% |
| Difficult to removethe device was hard to remove | 8 | 4.7% | 3.7% |
| Detachment of device or device componentpart of the device came off | 7 | 4.1% | 1.9% |
| Device-device incompatibility | 6 | 3.5% | 2.1% |
| Deflation problem | 3 | 1.8% | 2.4% |
| Device markings/labelling problema problem with the device markings or label | 3 | 1.8% | 0.6% |
| Improper or incorrect procedure or method | 3 | 1.8% | 0.6% |
| Insufficient device problem information | 3 | 1.8% | 0.7% |
| Material separation | 3 | 1.8% | 1.3% |
| Delivered as unsterile product | 2 | 1.2% | 0.4% |
| Device contamination with chemical or other material | 2 | 1.2% | 0.4% |
| Inflation problem | 2 | 1.2% | 3.2% |
| Material deformation | 2 | 1.2% | 0.9% |
| Obstruction of flow | 2 | 1.2% | 0.4% |
| Retraction problem | 2 | 1.2% | 0.9% |
| Crackthe device cracked | 1 | 0.6% | 0.4% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.6% | 0.2% |
| Difficult to insertthe device was hard to insert | 1 | 0.6% | 0.4% |
| Entrapment of device | 1 | 0.6% | 0.4% |
| Material frayed | 1 | 0.6% | 0% |
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 |
|---|---|---|
| Restenosis | 101 | 59.1% |
| Hemorrhage/blood loss/bleeding | 30 | 17.5% |
| Thrombosis/thrombus | 29 | 17% |
| Stenosis | 22 | 12.9% |
| Aneurysm | 15 | 8.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 9 | 5.3% |
| Fistula | 7 | 4.1% |
| High blood pressure/ hypertension | 4 | 2.3% |
| Obstruction/occlusion | 4 | 2.3% |
| Swelling/ edema | 3 | 1.8% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 1.2% |
| Perforation of vessels | 2 | 1.2% |
| Bradycardiaslow heart rate | 1 | 0.6% |
| Chest painchest pain | 1 | 0.6% |
| Discomfortdiscomfort | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lutonix 035AV Drug Coated PTA Dilation Catheter | Product code PRC | All MAUDE reports |
|---|---|---|---|
| Reports | 171 | 536 | 26,136,888 |
| Share of that pool | — | 31.9% | 0% |
| Classified as death, per 1,000 reports | 29 | 15 | 9 |
| Classified as injury | 77.8% | 79.1% | 36.2% |
| Classified as malfunction | 19.3% | 19.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 PRC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| In Pact Av Access | 692 | 94 | 1.2% |
| Lutonix 035 Drug Coated Balloon Pta Catheter | 1,026 | 2 | 0.4% |
| Unspecified Bd Catheter | 251 | 0 | 0% |
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 Lutonix 035AV Drug Coated PTA Dilation Catheter reports
How many FDA reports name Lutonix 035AV Drug Coated PTA Dilation Catheter?
171 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.
What kinds of events are reported?
injury (77.8%), malfunction (19.3%) and death (2.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (6.4%), difficult to remove (4.7%), detachment of device or device component (4.1%), device-device incompatibility (3.5%) and deflation problem (1.8%). 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 Lutonix 035AV Drug Coated PTA Dilation Catheter 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.