Device manufacturer, as written on reports

Av-Temecula-Ct: medical device reports filed with FDA

77,601 reports name it as the manufacturer of the device involved, 2009–2019.

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.

77,601
reports naming it as manufacturer: 0.3% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 34%
classified as malfunction: 62.3% across all reports; 3.2%
classified as death, as reported: 0.9% across all reports

77,601 medical device reports received by FDA give Av-Temecula-Ct as the manufacturer of the device involved, 0.3% of the MAUDE database, from June 2009 to November 2019. 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 (62.8%), malfunction (34%) and death (3.2%). 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
Perclose Proglide 6f Suture Mediated Closure Smc System	Device, hemostasis, vascular	23,559	0	0.3%
Xience V Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	4,257	9	11.6%
Nc Trek Coronary Dilatation Catheter	Catheters, transluminal coronary angioplasty, percutaneous	3,846	0	0.5%
Starclose Se Vascular Closure System	Device, hemostasis, vascular	3,835	0	0.4%
Xience Xpedition Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	3,327	0	4%
MITRACLIP SYSTEM Clip Delivery System	Mitral valve repair devices	2,227	299	14.9%
Mitraclip System Clip Delivery System Nt	Mitral valve repair devices	2,124	0	4.6%
Xience Alpine Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	2,092	0	3.2%
XIENCE PRIME Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	1,848	13	6.3%
Trek Coronary Dilatation Catheter	Catheters, transluminal coronary angioplasty, percutaneous	1,762	3	1.1%
Promus Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	1,732	0	11.3%
Graftmaster Rx Coronary Stent Graft System	Stent, coronary	1,414	0	13.1%
Armada 35 PTA Catheter	Catheter, angioplasty, peripheral, transluminal	1,253	9	0.2%
Mini Trek Coronary Dilatation Catheter	Catheters, transluminal coronary angioplasty, percutaneous	1,209	0	0.5%
Xience Prime Ll Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	1,158	0	4.5%
Mitraclip System Steerable Guide Catheter	Catheter, steerable	1,136	16	3%
Supera Self-Expanding Stent System	Stent, superficial femoral artery	1,075	0	0.9%
Mitraclip Xtr Delivery System	Mitral valve repair devices	1,003	0	4.8%
Absorb Bioresorbable Vascular Scaffold System	Absorbable coronary drug-eluting stent	851	11	8.3%
Jostent Graftmaster	Stent, coronary	750	0	23.5%
Prostar Xl Suture-Mediated Closure	Device, hemostasis, vascular	711	0	3.1%
Multi-Link Rx Vision Coronary Stent System	Stent, coronary	593	0	4.2%
XIENCE Sierra Everolimus Eluting Coronary Stent System	Coronary drug-eluting stent	566	4	4.3%
Rx Acculink Carotid Stent System	Stent, carotid	525	0	9.3%
Omnilink Elite Peripheral Stent System	Stent, iliac	519	0	0.6%
Mitraclip Ntr Delivery System	Mitral valve repair devices	509	0	2.6%
Armada 14 Pta Catheter	Catheter, angioplasty, peripheral, transluminal	480	0	0%
Emboshield Nav6 Embolic Protection System	Temporary carotid catheter for embolic capture	480	0	1.7%
Voyager Nc Coronary Dilatation Catheter	Catheters, transluminal coronary angioplasty, percutaneous	423	0	0.5%
Multi-Link 8	Stent, coronary	374	1	1.6%

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
MGB	Device, hemostasis, vascular	28,401	36.6%
NIQ	Coronary drug-eluting stent	17,023	21.9%
LOX	Catheters, transluminal coronary angioplasty, percutaneous	8,562	11%
NKM	Mitral valve repair devices	5,872	7.6%
MAF	Stent, coronary	4,050	5.2%
DQX	Wire, guide, catheter	3,207	4.1%
LIT	Catheter, angioplasty, peripheral, transluminal	2,737	3.5%
NIP	Stent, superficial femoral artery	1,188	1.5%
DRA	Catheter, steerable	1,138	1.5%
NIM	Stent, carotid	919	1.2%

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

Death3.2%2,495

Injury62.8%48,753

Malfunction34%26,353

Other0%0

Not given0%0

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

Questions about Av-Temecula-Ct reports

How many FDA device reports name Av-Temecula-Ct as manufacturer?

77,601 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Perclose Proglide 6f Suture Mediated Closure Smc System (23,559), Xience V Everolimus Eluting Coronary Stent System (4,257), Nc Trek Coronary Dilatation Catheter (3,846), Starclose Se Vascular Closure System (3,835) and Xience Xpedition Everolimus Eluting Coronary Stent System (3,327).

Which device types does it report on?

device, hemostasis, vascular (36.6%), coronary drug-eluting stent (21.9%), catheters, transluminal coronary angioplasty, percutaneous (11%) and mitral valve repair devices (7.6%).

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.