Devices › Drug-eluting peripheral transluminal angioplasty catheter
Device brand name · Drug coated balloon pta catheter
Lutonix 035 Drug Coated Balloon Pta Catheter: medical device reports filed with FDA
1,026 reports name it, 2015–2025. Manufacturer given most often on reports: C R Bard Gfo. Product code ONU.
- 1,026
- device reports naming the brand
- 0% of all MAUDE reports · about 90 a year
- 2
- reports, 12 months to August 2026
- 11 in the 12 months before
- 12.8%
- classified as malfunction
- 24.4% across the product code
- 0.4%
- classified as death, as reported
- 4 reports · not verified by FDA
1,026 medical device reports received by FDA name the brand "Lutonix 035 Drug Coated Balloon Pta Catheter" (drug coated balloon pta catheter); the manufacturer given most often on reports is C R Bard Gfo; received from February 2015 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
2 reports arrived in the 12 months to August 2026, down 82% from 11 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 (86.8%), malfunction (12.8%) and death (0.4%); across all drug-eluting peripheral transluminal angioplasty catheter reports (product code ONU) death is recorded in 8.9% and malfunction in 24.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material rupture (10%), difficult to remove (1.9%) and deflation problem (1.3%). The patient problems coded most often are reocclusion, intimal dissection and thrombosis. 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 5,911 reports carrying product code ONU. 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 | 103 | 10% | 9.6% |
| Difficult to removethe device was hard to remove | 19 | 1.9% | 1.9% |
| Deflation problem | 13 | 1.3% | 1.5% |
| Retraction problem | 11 | 1.1% | 0.2% |
| Torn material | 8 | 0.8% | 0.1% |
| Device-device incompatibility | 7 | 0.7% | 0.4% |
| Difficult to advance | 6 | 0.6% | 0.3% |
| Inflation problem | 6 | 0.6% | 4.6% |
| Material split, cut or torn | 6 | 0.6% | 0.1% |
| Detachment of device or device componentpart of the device came off | 4 | 0.4% | 1.2% |
| Off-label use | 4 | 0.4% | 0.1% |
| Occlusion within devicethe device blocked | 3 | 0.3% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.2% | 0.2% |
| Material twisted/bent | 2 | 0.2% | 2.6% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.2% | 0% |
| Scratched material | 2 | 0.2% | 0% |
| Crackthe device cracked | 1 | 0.1% | 0% |
| Defective devicethe device was defective | 1 | 0.1% | 1.5% |
| Delivered as unsterile product | 1 | 0.1% | 0.1% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.1% | 0.1% |
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 |
|---|---|---|
| Reocclusion | 729 | 71.1% |
| Intimal dissection | 66 | 6.4% |
| Thrombosis | 60 | 5.8% |
| Claudication | 27 | 2.6% |
| Hypersensitivity/allergic reaction | 19 | 1.9% |
| Injurya physical injury | 13 | 1.3% |
| Swellingswelling | 10 | 1% |
| Painpain, site not specified | 8 | 0.8% |
| Embolism | 6 | 0.6% |
| Rashskin rash | 6 | 0.6% |
| Necrosisdeath of tissue | 5 | 0.5% |
| No patient involvement | 5 | 0.5% |
| High blood pressure/ hypertension | 4 | 0.4% |
| Gangrenedeath of tissue | 3 | 0.3% |
| Perforation of vessels | 3 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lutonix 035 Drug Coated Balloon Pta Catheter | Product code ONU | All MAUDE reports |
|---|---|---|---|
| Reports | 1,026 | 5,911 | 26,136,888 |
| Share of that pool | — | 17.4% | 0% |
| Classified as death, per 1,000 reports | 4 | 89 | 9 |
| Classified as injury | 86.8% | 66.6% | 36.2% |
| Classified as malfunction | 12.8% | 24.4% | 62.3% |
| Filed by the manufacturer | 99.8% | 99.4% | 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 ONU
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| In Pact Admiral Paclitaxel-Eluting Pta Balloon Catheter | 1,423 | 104 | 6.5% |
| Stellarex 0 035 Otw Drug-Coated Angioplasty Balloon | 1,317 | 4 | 28.1% |
| Ranger Paclitaxel-Coated PTA Balloon Catheter | 432 | 60 | 0.7% |
| Ranger | 491 | 151 | 1.2% |
| In Pact Av Access | 692 | 94 | 1.2% |
| In Pact Pacific | 223 | 0 | 0% |
| Lutonix 035AV Drug Coated PTA Dilation Catheter | 171 | 16 | 2.9% |
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 035 Drug Coated Balloon Pta Catheter reports
How many FDA reports name Lutonix 035 Drug Coated Balloon Pta Catheter?
1,026 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
injury (86.8%), malfunction (12.8%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (10%), difficult to remove (1.9%), deflation problem (1.3%), retraction problem (1.1%) and torn material (0.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Lutonix 035 Drug Coated Balloon Pta 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.