Device manufacturer, as written on reports
Bard Peripheral Vascular: medical device reports filed with FDA
38,465 reports name it as the manufacturer of the device involved, 2003–2026.
- 38,465
- reports naming it as manufacturer
- 0.2% of all MAUDE reports
- 3,516
- reports, 12 months to August 2026
- 2,139 in the 12 months before
- 82.2%
- classified as malfunction
- 62.3% across all reports
- 1.2%
- classified as death, as reported
- 0.9% across all reports
38,465 medical device reports received by FDA give Bard Peripheral Vascular as the manufacturer of the device involved, 0.2% of the MAUDE database, from July 2003 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
3,516 reports arrived in the 12 months to August 2026, up 64% from 2,139 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 (82.2%), injury (16.5%) and death (1.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| EnCor Biopsy Probe | Instrument, biopsy | 5,205 | 15 | 0% |
| Maxcore | Instrument, biopsy | 4,003 | 1,890 | 0% |
| Bard Max-Core Disposable Core Biopsy Instrument | Instrument, biopsy | 2,599 | 0 | 0% |
| Bard Max-Core Disposable Biopsy Instrument | Instrument, biopsy | 2,319 | 0 | 0% |
| G2 Filter System - Femoral | Filter, intravascular, cardiovascular | 1,111 | 0 | 3.7% |
| Denali Femoral System | Filter, intravascular, cardiovascular | 925 | 78 | 4.6% |
| Denali Jugular System | Filter, intravascular, cardiovascular | 700 | 45 | 6.3% |
| Eclipse Filter System - Femoral | Filter, intravascular, cardiovascular | 622 | 0 | 6% |
| Recovery Filter System | Filter, intravascular, cardiovascular | 588 | 4 | 3.6% |
| Conquest Pta Balloon Dilatation Catheter | Catheter, percutaneous | 503 | 0 | 0.2% |
| Conquest Pta Dilatation Catheter | Catheter, percutaneous | 498 | 0 | 0.2% |
| Fluency Plus Endovascular Stent Graft | System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment | 438 | 35 | 0.6% |
| Magnum Needle | Biopsy needle | 429 | 206 | 0% |
| Meridian Filter System - Femoral | Filter, intravascular, cardiovascular | 368 | 0 | 6.6% |
| Ultraverse RX | Catheter, angioplasty, peripheral, transluminal | 362 | 68 | 0% |
| Crosser | Catheter for crossing total occlusions | 361 | 57 | 0% |
| Flair Endovascular Stent Graft | System, endovascular graft, aortic aneurysm treatment | 352 | 0 | 0.3% |
| G2 Filter System - Jugular | Filter, intravascular, cardiovascular | 346 | 0 | 4.6% |
| Crosser Cto Recanalization Catheter | Catheter for crossing total occlusions | 345 | 0 | 0.3% |
| Recovery Filter | Filter, intravascular, cardiovascular | 344 | 0 | 4.8% |
| Conquest | Catheter, percutaneous | 337 | 70 | 0% |
| G2 Filter System | Filter, intravascular, cardiovascular | 314 | 11 | 1.4% |
| G2 Filter System Femoral | Filter, intravascular, cardiovascular | 306 | 0 | 1% |
| Dorado Pta Balloon Dilatation Catheter | Catheter, percutaneous | 288 | 0 | 0% |
| Monopty Disposable Core Biopsy Instrument | Instrument, biopsy | 282 | 0 | 0% |
| Denali Filter | Filter, intravascular, cardiovascular | 250 | 0 | 0.8% |
| Atlas Gold Pta Dilatation Catheter | Catheter, percutaneous | 213 | 0 | 0.4% |
| Marquee | Instrument, biopsy | 213 | 46 | 0% |
| Crosser Cto Recanalization Catheters | Catheter for crossing total occlusions | 212 | 0 | 0% |
| Meridian Filter System - Jugular | Filter, intravascular, cardiovascular | 202 | 0 | 9% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| KNW | Instrument, biopsy | 16,854 | 43.8% |
| DTK | Filter, intravascular, cardiovascular | 9,661 | 25.1% |
| DQY | Catheter, percutaneous | 3,924 | 10.2% |
| LIT | Catheter, angioplasty, peripheral, transluminal | 2,804 | 7.3% |
| PDU | Catheter for crossing total occlusions | 1,033 | 2.7% |
| FCG | Biopsy needle | 732 | 1.9% |
| PFV | System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment | 506 | 1.3% |
| PNO | Catheter, percutaneous, cutting/scoring | 340 | 0.9% |
| MIH | System, endovascular graft, aortic aneurysm treatment | 323 | 0.8% |
| FGE | Stents, drains and dilators for the biliary ducts | 242 | 0.6% |
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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Bard Peripheral Vascular reports
How many FDA device reports name Bard Peripheral Vascular as manufacturer?
38,465 reports through August 2026, 3,516 of them in the latest 12 months.
Which of its brands appear most often?
EnCor Biopsy Probe (5,205), Maxcore (4,003), Bard Max-Core Disposable Core Biopsy Instrument (2,599), Bard Max-Core Disposable Biopsy Instrument (2,319) and G2 Filter System - Femoral (1,111).
Which device types does it report on?
instrument, biopsy (43.8%), filter, intravascular, cardiovascular (25.1%), catheter, percutaneous (10.2%) and catheter, angioplasty, peripheral, transluminal (7.3%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.