Device manufacturer, as written on reports

Abbott Vascular: medical device reports filed with FDA

90,551 reports name it as the manufacturer of the device involved, 2002–2026.

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.

90,551
reports naming it as manufacturer: 0.4% of all MAUDE reports; 6,808
reports, 12 months to August 2026: 14,524 in the 12 months before; 22.8%
classified as malfunction: 62.3% across all reports; 1.7%
classified as death, as reported: 0.9% across all reports

90,551 medical device reports received by FDA give Abbott Vascular as the manufacturer of the device involved, 0.4% of the MAUDE database, from April 2002 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

6,808 reports arrived in the 12 months to August 2026, down 53% from 14,524 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 (75.4%), malfunction (22.8%) and death (1.7%). 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
Perclose Proglide 6f Suture Mediated Closure Smc System	Device, hemostasis, vascular	19,112	0	0.3%
Perclose ProStyle Suture-Mediated Closure and Repair System	Device, hemostasis, vascular	16,441	22	0%
Perclose ProStyle	Device, hemostasis, vascular	12,871	2,308	0.1%
Perclose ProGlide	Device, hemostasis, vascular	3,374	653	0.9%
Mitraclip G4 Clip Delivery System	Mitral valve repair devices	3,173	0	2.3%
MITRACLIP SYSTEM Clip Delivery System	Mitral valve repair devices	2,141	299	14.9%
Xience Skypoint Drug Eluting Coronary Stent Delivery System	Coronary drug-eluting stent	1,063	0	1.8%
XIENCE Sierra	Coronary drug-eluting stent	893	151	3.9%
Starclose Vascular Closure System	Device, hemostasis, vascular	884	8	1.2%
Xience Xpedition Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	837	0	4%
Nc Trek Coronary Dilatation Catheter	Catheters, transluminal coronary angioplasty, percutaneous	825	0	0.5%
Graftmaster Rx Coronary Stent Graft System	Stent, coronary	729	0	13.1%
XIENCE Sierra Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	701	4	4.3%
XIENCE Xpedition	Coronary drug-eluting stent	660	129	3.8%
Armada	Catheter, angioplasty, peripheral, transluminal	657	305	0.1%
Mitraclip Xtr Clip Delivery System	Mitral valve repair devices	586	0	3.3%
Graftmaster	Stent, coronary	568	131	9.9%
Xience Alpine Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	565	0	3.2%
Supera Self-Expanding Stent System	Stent, superficial femoral artery	563	0	0.9%
Armada 35 PTA Catheter	Catheter, angioplasty, peripheral, transluminal	548	9	0.2%
20/30 Priority Pack Indeflator	Syringe, balloon inflation	517	0	0%
XIENCE Skypoint	Coronary drug-eluting stent	513	269	4.6%
G4 Steerable Guiding Catheter	Catheter, steerable	502	0	1.6%
Starclose Se Vascular Closure System	Device, hemostasis, vascular	483	0	0.4%
Supera	Stent, superficial femoral artery	457	159	4.6%
XIENCE PRIME Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	449	13	6.3%
XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	427	7	4.1%
Nc Trek Neo	Catheters, transluminal coronary angioplasty, percutaneous	425	168	0.9%
Mitraclip Ntr Clip Delivery System	Mitral valve repair devices	414	0	4.4%
MitraClip G5 Delivery System	Mitral valve repair devices	392	1,335	1.4%

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
MGB	Device, hemostasis, vascular	55,330	61.1%
NIQ	Coronary drug-eluting stent	8,349	9.2%
NKM	Mitral valve repair devices	7,623	8.4%
LOX	Catheters, transluminal coronary angioplasty, percutaneous	4,110	4.5%
DQX	Wire, guide, catheter	3,120	3.4%
NIP	Stent, superficial femoral artery	1,783	2%
LIT	Catheter, angioplasty, peripheral, transluminal	1,628	1.8%
MAF	Stent, coronary	1,293	1.4%
DRA	Catheter, steerable	1,159	1.3%
MAV	Syringe, balloon inflation	1,037	1.1%

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

Death1.7%1,524

Injury75.4%68,243

Malfunction22.8%20,630

Other0.1%100

Not given0.1%54

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 reports

How many FDA device reports name Abbott Vascular as manufacturer?

90,551 reports through August 2026, 6,808 of them in the latest 12 months.

Which of its brands appear most often?

Perclose Proglide 6f Suture Mediated Closure Smc System (19,112), Perclose ProStyle Suture-Mediated Closure and Repair System (16,441), Perclose ProStyle (12,871), Perclose ProGlide (3,374) and Mitraclip G4 Clip Delivery System (3,173).

Which device types does it report on?

device, hemostasis, vascular (61.1%), coronary drug-eluting stent (9.2%), mitral valve repair devices (8.4%) and catheters, transluminal coronary angioplasty, percutaneous (4.5%).

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.