Devices › Catheter, angioplasty, peripheral, transluminal
Device brand name · Catheter angioplasty peripheral translumina
Fortrex 0 035 Otw Pta Balloon Catheter: medical device reports filed with FDA
201 reports name it, 2016–2026. Manufacturer given most often on reports: Covidien. Product code LIT.
- 201
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 29
- reports, 12 months to August 2026
- 38 in the 12 months before
- 71.1%
- classified as malfunction
- 83.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 201 reports that name the brand "Fortrex 0 035 Otw Pta Balloon Catheter" (catheter angioplasty peripheral translumina), received between January 2016 and August 2026; the manufacturer given most often on reports is Covidien. Spellings of one product vary from report to report.
29 reports arrived in the 12 months to August 2026, down 24% from 38 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 malfunction (71.1%) and injury (28.9%); across all catheter, angioplasty, peripheral, transluminal reports (product code LIT) death is recorded in 0.5% and malfunction in 83.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are burst container or vessel (65.7%), leak/splash (12.4%) and detachment of device or device component (7.5%). The patient problems coded most often are stenosis, device embedded in tissue or plaque and embolism. 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 35,907 reports carrying product code LIT. 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 |
|---|---|---|---|
| Burst container or vessel | 132 | 65.7% | 11.4% |
| Leak/splashthe device leaked | 25 | 12.4% | 6.1% |
| Detachment of device or device componentpart of the device came off | 15 | 7.5% | 3.7% |
| Difficult to removethe device was hard to remove | 7 | 3.5% | 9.1% |
| Inflation problem | 6 | 3% | 4.1% |
| Deflation problem | 4 | 2% | 4.5% |
| Device markings/labelling problema problem with the device markings or label | 4 | 2% | 0.2% |
| Component missing | 3 | 1.5% | 0.2% |
| Material deformation | 3 | 1.5% | 1.3% |
| Nonstandard device | 3 | 1.5% | 0% |
| Material twisted/bent | 2 | 1% | 0.4% |
| Deformation due to compressive stress | 1 | 0.5% | 0.1% |
| Device contamination with chemical or other material | 1 | 0.5% | 0.2% |
| Difficult to advance | 1 | 0.5% | 1% |
| Difficult to insertthe device was hard to insert | 1 | 0.5% | 0.6% |
| Entrapment of device | 1 | 0.5% | 1.3% |
| Fracturea broken bone | 1 | 0.5% | 0.6% |
| Material puncture/hole | 1 | 0.5% | 0.5% |
| Material rupture | 1 | 0.5% | 44.2% |
| Migrationthe device moved from where it was placed | 1 | 0.5% | 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 |
|---|---|---|
| Stenosis | 10 | 5% |
| Device embedded in tissue or plaque | 7 | 3.5% |
| Embolism | 3 | 1.5% |
| Hematomaa collection of blood under the skin or in tissue | 3 | 1.5% |
| Hemorrhage/blood loss/bleeding | 3 | 1.5% |
| Restenosis | 3 | 1.5% |
| Thrombosis/thrombus | 3 | 1.5% |
| Occlusion | 2 | 1% |
| Painpain, site not specified | 2 | 1% |
| Vascular dissection | 2 | 1% |
| Embolism/embolus | 1 | 0.5% |
| Fever | 1 | 0.5% |
| Inflammationinflammation | 1 | 0.5% |
| Injurya physical injury | 1 | 0.5% |
| Obstruction/occlusion | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fortrex 0 035 Otw Pta Balloon Catheter | Product code LIT | All MAUDE reports |
|---|---|---|---|
| Reports | 201 | 35,907 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 28.9% | 15.1% | 36.2% |
| Classified as malfunction | 71.1% | 83.5% | 62.3% |
| Filed by the manufacturer | 99.5% | 97.6% | 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 LIT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Coyote? ES | 5,428 | 438 | 0% |
| 2cm Peripheral Cutting Balloon | 3,202 | 314 | 0% |
| Armada 35 PTA Catheter | 1,864 | 9 | 0.2% |
| Sterling | 4,963 | 300 | 0.1% |
| Coyote? | 1,767 | 122 | 0.1% |
| Mustang | 5,969 | 491 | 0.3% |
| Armada 18 Pta Catheter | 651 | 0 | 0% |
| Armada | 680 | 305 | 0.1% |
| Gladiator? Elite | 545 | 59 | 0% |
| Armada 14 Pta Catheter | 746 | 0 | 0% |
| Ultra-Thin Balloon Dilatation Catheter | 488 | 0 | 0.4% |
| Fox Plus Pta Catheter | 385 | 0 | 0% |
| Ultraverse RX | 369 | 68 | 0% |
| Evercross 035 | 427 | 30 | 2.6% |
| Sterling Es Pta Balloon Dilatation Catheter | 333 | 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 Fortrex 0 035 Otw Pta Balloon Catheter reports
How many FDA reports name Fortrex 0 035 Otw Pta Balloon Catheter?
201 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 29 in the latest 12 months.
What kinds of events are reported?
malfunction (71.1%) and injury (28.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
burst container or vessel (65.7%), leak/splash (12.4%), detachment of device or device component (7.5%), difficult to remove (3.5%) and inflation problem (3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Fortrex 0 035 Otw Pta Balloon 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.