Drug-eluting peripheral transluminal angioplasty catheter: medical device reports filed with FDA

5,911 reports carry this product code, 2015–2026; 8 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,911
reports with this product code: 0% of all MAUDE reports; 444
reports, 12 months to August 2026: 423 in the 12 months before; 24.4%
classified as malfunction: 62.3% across all reports; 8.9%
classified as death, as reported: 0.9% across all reports

Product code ONU is FDA's classification for "Drug-eluting peripheral transluminal angioplasty catheter" (unknown panel), a class 3 device. 5,911 medical device reports carry this product code, 0% of the MAUDE database, from January 2015 to August 2026.

444 reports arrived in the 12 months to August 2026, close to the 423 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 injury (66.6%), malfunction (24.4%) and death (8.9%). 8 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
In Pact Admiral Paclitaxel-Eluting Pta Balloon Catheter	1,423	104	6.5%	18.1%
Stellarex 0 035 Otw Drug-Coated Angioplasty Balloon	1,317	4	28.1%	2.6%
Lutonix 035 Drug Coated Balloon Pta Catheter	1,009	2	0.4%	12.8%
Ranger Paclitaxel-Coated PTA Balloon Catheter	432	60	0.7%	57.2%
Ranger	418	151	1.2%	52.7%
In Pact Av Access	399	94	1.2%	10%
In Pact Pacific	223	0	0%	98.2%
Lutonix 035AV Drug Coated PTA Dilation Catheter	1	16	2.9%	19.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Ireland	1,625	27.5%
Spectranetics	1,380	23.3%
The Spectranetics	27	0.5%
Invatec	15	0.3%
Medtronic Vascular	5	0.1%
Medtronic Mexico	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death8.9%528

Injury66.6%3,937

Malfunction24.4%1,445

Other0%0

Not given0%1

Who filed

Manufacturer report99.4%5,878

Voluntary report0.1%8

User facility report0%0

Distributor report0%0

Not given0.4%25

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Material rupture	566	9.6%
Inflation problem	270	4.6%
Burst container or vessel	193	3.3%
Material twisted/bent	155	2.6%
Leak/splashthe device leaked	112	1.9%
Difficult to removethe device was hard to remove	111	1.9%
Defective devicethe device was defective	88	1.5%
Deflation problem	88	1.5%
Detachment of device or device componentpart of the device came off	73	1.2%
Entrapment of device	43	0.7%
Occlusion within devicethe device blocked	40	0.7%
Failure to deflate	36	0.6%
Material deformation	35	0.6%
Insufficient device problem information	28	0.5%
Device-device incompatibility	22	0.4%
Difficult to advance	19	0.3%
Material integrity problema problem with the device material	18	0.3%
Breakthe device broke	16	0.3%
Device operates differently than expectedthe device behaved unexpectedly	14	0.2%
Difficult to insertthe device was hard to insert	14	0.2%

Questions about drug-eluting peripheral transluminal angioplasty catheter reports

What is product code ONU?

FDA's classification code for "Drug-eluting peripheral transluminal angioplasty catheter", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,911 reports through August 2026, 444 of them in the latest 12 months.

Which brands appear most often?

In Pact Admiral Paclitaxel-Eluting Pta Balloon Catheter (1,423), Stellarex 0 035 Otw Drug-Coated Angioplasty Balloon (1,317), Lutonix 035 Drug Coated Balloon Pta Catheter (1,009), Ranger Paclitaxel-Coated PTA Balloon Catheter (432) and Ranger (418). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.