Device manufacturer, as written on reports

Abbott Vascular-Vascular Solutions: medical device reports filed with FDA

2,200 reports name it as the manufacturer of the device involved, 2007–2010.

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.

2,200
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 19.8%
classified as malfunction: 62.3% across all reports; 4%
classified as death, as reported: 0.9% across all reports

2,200 medical device reports received by FDA give Abbott Vascular-Vascular Solutions as the manufacturer of the device involved, 0% of the MAUDE database, from May 2007 to November 2010. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 injury (75.6%), malfunction (19.8%) and death (4%). 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
Rx Acculink Carotid Stent System	Stent, carotid	577	0	9.3%
Starclose Se Vascular Closure System	Device, hemostasis, vascular	292	0	0.4%
Xact Carotid Stent System	Stent, carotid	232	0	9.5%
Perclose Proglide 6f Suture Mediated Closure Smc System	Device, hemostasis, vascular	223	0	0.3%
Rx Accunet Embolic Protection System	Temporary carotid catheter for embolic capture	120	0	2.1%
Absolute 035 Self Expanding Stent System	Stents, drains and dilators for the biliary ducts	80	0	1.1%
Starclose Vascular Closure System	Device, hemostasis, vascular	79	8	1.2%
Emboshield Nav6 Embolic Protection System	Temporary carotid catheter for embolic capture	68	0	1.7%
Absolute Pro .035 Self Expanding Stent System	Stents, drains and dilators for the biliary ducts	50	38	0.2%
Rx Viatrac 14 Plus Peripheral Dilatation Catheter	Catheter, angioplasty, peripheral, transluminal	35	0	1.3%
Fox Plus Pta Catheter	Catheter, angioplasty, peripheral, transluminal	25	0	0%
Prostar Xl Suture-Mediated Closure	Device, hemostasis, vascular	25	0	3.1%
Foxcross Pta Catheter	Catheter, angioplasty, peripheral, transluminal	22	0	0%
Fox Sv Pta Catheter	Catheter, angioplasty, peripheral, transluminal	19	0	0.3%
Rx Herculink Elite Stent System	Stent, renal	19	0	1.7%
Xpert Self-Expanding Transhepatic Biliary Stent System	Stents, drains and dilators for the biliary ducts	11	0	0%
Perclose A-T Suture Mediated Closure Smc System	Device, hemostasis, vascular	5	0	1%
Omnilink Elite Peripheral Stent System	Stent, iliac	3	0	0.6%

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
NIM	Stent, carotid	825	37.5%
MGB	Device, hemostasis, vascular	655	29.8%
FGE	Stents, drains and dilators for the biliary ducts	295	13.4%
NTE	Temporary carotid catheter for embolic capture	197	9%
LIT	Catheter, angioplasty, peripheral, transluminal	183	8.3%
NFA	Temporary coronary saphenous vein bypass graft for embolic protection	26	1.2%
DQX	Wire, guide, catheter	15	0.7%
MAF	Stent, coronary	2	0.1%
DQY	Catheter, percutaneous	1	0%
LOX	Catheters, transluminal coronary angioplasty, percutaneous	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

Death4%88

Injury75.6%1,663

Malfunction19.8%435

Other0.6%13

Not given0%1

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Abbott Vascular-Vascular Solutions reports

How many FDA device reports name Abbott Vascular-Vascular Solutions as manufacturer?

2,200 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Rx Acculink Carotid Stent System (577), Starclose Se Vascular Closure System (292), Xact Carotid Stent System (232), Perclose Proglide 6f Suture Mediated Closure Smc System (223) and Rx Accunet Embolic Protection System (120).

Which device types does it report on?

stent, carotid (37.5%), device, hemostasis, vascular (29.8%), stents, drains and dilators for the biliary ducts (13.4%) and temporary carotid catheter for embolic capture (9%).

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.