Devices › Catheter, angioplasty, peripheral, transluminal
Device brand name · Catheter angioplasty peripheral translumina
2cm Peripheral Cutting Balloon: medical device reports filed with FDA
3,202 reports name it, 2005–2026. Manufacturer given most often on reports: Boston Scientific. Product code LIT.
- 3,202
- device reports naming the brand
- 0% of all MAUDE reports · about 149 a year
- 314
- reports, 12 months to August 2026
- 392 in the 12 months before
- 95.6%
- 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 3,202 reports that name the brand "2cm Peripheral Cutting Balloon" (catheter angioplasty peripheral translumina), received between January 2005 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
314 reports arrived in the 12 months to August 2026, down 20% from 392 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 (95.6%) and injury (4.4%); 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 material rupture (81.5%), leak/splash (5.4%) and detachment of device or device component (3.8%). The patient problems coded most often are hematoma, device embedded in tissue or plaque and hemorrhage/blood loss/bleeding. 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 |
|---|---|---|---|
| Material rupture | 2,611 | 81.5% | 44.2% |
| Leak/splashthe device leaked | 173 | 5.4% | 6.1% |
| Detachment of device or device componentpart of the device came off | 123 | 3.8% | 3.7% |
| Difficult to removethe device was hard to remove | 110 | 3.4% | 9.1% |
| Detachment of device component | 47 | 1.5% | 2.7% |
| Inflation problem | 46 | 1.4% | 4.1% |
| Device dislodged or dislocated | 44 | 1.4% | 0.2% |
| Material deformation | 41 | 1.3% | 1.3% |
| Deflation problem | 39 | 1.2% | 4.5% |
| Material integrity problema problem with the device material | 32 | 1% | 0.3% |
| Failure to advance | 18 | 0.6% | 1.3% |
| Material twisted/bent | 18 | 0.6% | 0.4% |
| Breakthe device broke | 17 | 0.5% | 3.2% |
| Device-device incompatibility | 17 | 0.5% | 0.4% |
| Failure to deflate | 14 | 0.4% | 0.1% |
| Difficult to advance | 12 | 0.4% | 1% |
| Bent | 10 | 0.3% | 0.1% |
| Device damaged by another device | 9 | 0.3% | 0.2% |
| Fluid/blood leak | 9 | 0.3% | 0.5% |
| Difficult to insertthe device was hard to insert | 8 | 0.2% | 0.6% |
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 |
|---|---|---|
| Hematomaa collection of blood under the skin or in tissue | 16 | 0.5% |
| Device embedded in tissue or plaque | 15 | 0.5% |
| Hemorrhage/blood loss/bleeding | 13 | 0.4% |
| Perforation of vessels | 10 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 9 | 0.3% |
| No patient involvement | 7 | 0.2% |
| Blood loss | 5 | 0.2% |
| Intimal dissection | 4 | 0.1% |
| Painpain, site not specified | 4 | 0.1% |
| Injurya physical injury | 3 | 0.1% |
| Laceration(s) | 3 | 0.1% |
| Vascular dissection | 3 | 0.1% |
| Inflammationinflammation | 2 | 0.1% |
| Complaint, ill-defined | 1 | 0% |
| Extravasation | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 2cm Peripheral Cutting Balloon | Product code LIT | All MAUDE reports |
|---|---|---|---|
| Reports | 3,202 | 35,907 | 26,136,888 |
| Share of that pool | — | 8.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 4.4% | 15.1% | 36.2% |
| Classified as malfunction | 95.6% | 83.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| 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% |
| Fox Sv Pta Catheter | 299 | 0 | 0.3% |
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." 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 2cm Peripheral Cutting Balloon reports
How many FDA reports name 2cm Peripheral Cutting Balloon?
3,202 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 314 in the latest 12 months.
What kinds of events are reported?
malfunction (95.6%) and injury (4.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material rupture (81.5%), leak/splash (5.4%), detachment of device or device component (3.8%), difficult to remove (3.4%) and detachment of device component (1.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that 2cm Peripheral Cutting Balloon 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.