Abbott Vascular medical device reports that give this manufacturer
- Name type
- Device manufacturer, as written on reports
What a report is
A report is not proof that the device was the cause of the event.
FDA says:
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.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
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.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
From April 2002 to September 2026, FDA received 90,721 medical device reports that give Abbott Vascular as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.
FDA received 5,720 reports in the 12 months to September 2026 and 14,602 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 5,720 (0.2%) give Abbott Vascular as the manufacturer. Manufacturer reports were 97.9% of the reports that name this manufacturer and 94.9% of all device reports.
The number of people who use the product is not in the data. A count is not a rate.
Why manufacturers report
FDA says:
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .
Data version
openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.
Brand names
The table has the 77 brand pages with 5 or more reports that give this manufacturer. 84 brand pages have a report in all. The rows are in order of name. A brand page with fewer reports is not in the table.
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Brand name | Product code | Reports | Reports, 12 months to September 2026 |
|---|---|---|---|
| 20/30 Priority Pack Accessory Kit | Syringe, balloon inflation | 44 | 0 |
| 20/30 Priority Pack Indeflator | Syringe, balloon inflation | 517 | 0 |
| Abbott | Set, administration, intravascular | 12 | 0 |
| Absolute Pro | Stent, iliac | 213 | 123 |
| Absolute Pro .035 Self Expanding Stent System | Stents, drains and dilators for the biliary ducts | 343 | 36 |
| Absolute Pro Ll Self-Expanding Stent System | Stent, iliac | 117 | 7 |
| Absolute Pro Vascular Self-Expanding Stent System | Stent, iliac | 45 | 0 |
| Absorb Bioresorbable Vascular Scaffold System | Absorbable coronary drug-eluting stent | 136 | 11 |
| Armada | Catheter, angioplasty, peripheral, transluminal | 657 | 279 |
| Armada 14 Pta Catheter | Catheter, angioplasty, peripheral, transluminal | 124 | 0 |
| Armada 18 Pta Catheter | Catheter, angioplasty, peripheral, transluminal | 254 | 0 |
| Armada 35 PTA Catheter | Catheter, angioplasty, peripheral, transluminal | 553 | 14 |
| Copilot | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass | 188 | 25 |
| Emboshield Nav6 | Temporary carotid catheter for embolic capture | 241 | 82 |
| Emboshield Nav6 Embolic Protection System | Temporary carotid catheter for embolic capture | 263 | 0 |
| Esprit | Ventilator, continuous, facility use | 192 | 119 |
| Fox Plus Pta Catheter | Catheter, angioplasty, peripheral, transluminal | 6 | 0 |
| G4 Steerable Guiding Catheter | Catheter, steerable | 502 | 0 |
| Graftmaster | Stent, coronary | 572 | 125 |
| Graftmaster Rx Coronary Stent Graft System | Stent, coronary | 729 | 0 |
| Hi-Torque Balance Middleweight | Wire, guide, catheter | 204 | 117 |
| Hi-Torque Command | Wire, guide, catheter | 189 | 74 |
| Hi-Torque Command 18 Guide Wire | Wire, guide, catheter | 73 | 0 |
| Indeflator | Syringe, balloon inflation | 322 | 18 |
| Mini Trek | Catheters, transluminal coronary angioplasty, percutaneous | 283 | 115 |
| Mini Trek Coronary Dilatation Catheter | Catheters, transluminal coronary angioplasty, percutaneous | 239 | 0 |
| Mitraclip Clip Delivery System | Mitral valve repair devices | 317 | 0 |
| Mitraclip G4 Clip Delivery System | Mitral valve repair devices | 3,173 | 0 |
| MitraClip G5 Delivery System | Mitral valve repair devices | 392 | 1,353 |
| Mitraclip Ntr Clip Delivery System | Mitral valve repair devices | 414 | 0 |
| MITRACLIP SYSTEM Clip Delivery System | Mitral valve repair devices | 2,141 | 268 |
| Mitraclip System Clip Delivery System Nt | Mitral valve repair devices | 141 | 0 |
| Mitraclip System Steerable Guide Catheter | Catheter, steerable | 286 | 16 |
| Mitraclip Xtr Clip Delivery System | Mitral valve repair devices | 586 | 0 |
| Nc Traveler Coronary Dilatation Catheter | Catheters, transluminal coronary angioplasty, percutaneous | 138 | 0 |
| Nc Trek | Catheters, transluminal coronary angioplasty, percutaneous | 159 | 38 |
| Nc Trek Coronary Dilatation Catheter | Catheters, transluminal coronary angioplasty, percutaneous | 825 | 0 |
| Nc Trek Neo | Catheters, transluminal coronary angioplasty, percutaneous | 428 | 155 |
| Nc Trek Neo Rx | Catheters, transluminal coronary angioplasty, percutaneous | 203 | 0 |
| Nc Trek Rx | Catheters, transluminal coronary angioplasty, percutaneous | 306 | 0 |
| Omnilink Elite | Stent, iliac | 205 | 114 |
| Omnilink Elite Peripheral Stent System | Stent, iliac | 156 | 0 |
| Perclose | Device, hemostasis, vascular | 20 | 8 |
| Perclose A-T Suture Mediated Closure Smc System | Device, hemostasis, vascular | 10 | 0 |
| Perclose ProGlide | Device, hemostasis, vascular | 3,378 | 500 |
| Perclose Proglide 6f Suture Mediated Closure Smc System | Device, hemostasis, vascular | 19,112 | 0 |
| Perclose ProStyle | Device, hemostasis, vascular | 12,916 | 1,579 |
| Perclose ProStyle Suture-Mediated Closure and Repair System | Device, hemostasis, vascular | 16,454 | 35 |
| Proglide | Device, hemostasis, vascular | 176 | 0 |
| Prostar Xl Suture-Mediated Closure | Device, hemostasis, vascular | 188 | 0 |
| StarClose SE | Device, hemostasis, vascular | 265 | 65 |
| Starclose Se Vascular Closure System | Device, hemostasis, vascular | 483 | 0 |
| Starclose Vascular Closure System | Device, hemostasis, vascular | 884 | 8 |
| Steerable Guide Catheter | Catheter, steerable | 254 | 29 |
| Supera | Stent, superficial femoral artery | 457 | 147 |
| Supera Peripheral Stent System | Stent, superficial femoral artery | 229 | 3 |
| Supera Self-Expanding Stent System | Stent, superficial femoral artery | 563 | 0 |
| The Closer Ak | Device, hemostasis, vascular | 7 | 0 |
| Trek | Catheters, transluminal coronary angioplasty, percutaneous | 259 | 90 |
| TREK Coronary Dilatation Catheter | Catheters, transluminal coronary angioplasty, percutaneous | 344 | 4 |
| Trek Rx Coronary Dilatation Catheter | Catheters, transluminal coronary angioplasty, percutaneous | 97 | 0 |
| TriClip G5 Delivery System | Tricuspid valve repair device, percutaneously delivered | 139 | 482 |
| UNK Perclose | Device, hemostasis, vascular | 279 | 37 |
| Xience Alpine | Coronary drug-eluting stent | 299 | 99 |
| Xience Alpine Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 565 | 0 |
| XIENCE Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 125 | 32 |
| Xience Prime | Coronary drug-eluting stent | 169 | 22 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 449 | 10 |
| Xience Prime Ll Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 202 | 0 |
| XIENCE Sierra | Coronary drug-eluting stent | 893 | 139 |
| XIENCE Sierra Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 701 | 4 |
| XIENCE Skypoint | Coronary drug-eluting stent | 522 | 264 |
| Xience Skypoint Drug Eluting Coronary Stent Delivery System | Coronary drug-eluting stent | 1,063 | 0 |
| Xience V Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 201 | 9 |
| XIENCE Xpedition | Coronary drug-eluting stent | 660 | 117 |
| XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 427 | 4 |
| Xience Xpedition Everolimus Eluting Coronary Stent System | Coronary drug-eluting stent | 837 | 0 |
Device types
The table has the 21 device types with 5 or more reports that give this manufacturer. The rows are in order of name.
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Device type | Product code | Reports |
|---|---|---|
| Absorbable coronary drug-eluting stent | PNY | 170 |
| Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass | DTL | 219 |
| Catheter, angioplasty, peripheral, transluminal | LIT | 1,636 |
| Catheter, percutaneous | DQY | 5 |
| Catheter, steerable | DRA | 1,159 |
| Catheters, transluminal coronary angioplasty, percutaneous | LOX | 4,131 |
| Clip, implantable | FZP | 193 |
| Coronary covered stent | NIV | 92 |
| Coronary drug-eluting stent | NIQ | 8,376 |
| Device, hemostasis, vascular | MGB | 55,397 |
| Dressing, wound, drug | FRO | 7 |
| Mitral valve repair devices | NKM | 7,623 |
| Stent, carotid | NIM | 12 |
| Stent, coronary | MAF | 1,293 |
| Stent, iliac | NIO | 935 |
| Stent, superficial femoral artery | NIP | 1,783 |
| Stents, drains and dilators for the biliary ducts | FGE | 58 |
| Syringe, balloon inflation | MAV | 1,037 |
| Temporary carotid catheter for embolic capture | NTE | 289 |
| Tricuspid valve repair device, percutaneously delivered | NPS | 140 |
| Wire, guide, catheter | DQX | 3,134 |
Reports by month
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Event type
| Event type | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 1,531 | 1.7% | |
| Injury | 68,301 | 75.3% | |
| Malfunction | 20,735 | 22.9% | |
| Other | 100 | 0.1% | |
| Not given | 54 | 0.1% |
The event type is the classification that the reporter gave. FDA does not verify it.
Official pages
- Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. Abbott Vascular: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/abbott-vascular/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.
The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Does a large count say something about the manufacturer?
Not by itself. FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
What event types do the reports record?
Death (1,531), injury (68,301), malfunction (20,735) and other (100). The event type is the classification that the reporter gave. FDA does not verify it.
Why can one company have more than one page?
The manufacturer field is free text on the report. This page counts the 90,721 reports with the name Abbott Vascular after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.