Device manufacturer, as written on reports

Invatec: medical device reports filed with FDA

1,071 reports name it as the manufacturer of the device involved, 2009–2024.

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.

1,071
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 1 in the 12 months before; 45.2%
classified as malfunction: 62.3% across all reports; 6.1%
classified as death, as reported: 0.9% across all reports

1,071 medical device reports received by FDA give Invatec as the manufacturer of the device involved, 0% of the MAUDE database, from May 2009 to December 2024. 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, against 1 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 (48.3%), malfunction (45.2%) and death (6.1%). 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
Admiral Xtreme	Catheter, angioplasty, peripheral, transluminal	132	0	4.7%
Amphirion Deep Pta Balloon Catheter	Catheter, percutaneous	110	0	17.4%
Pacific Xtreme	Catheter, angioplasty, peripheral, transluminal	77	0	4%
Pacific Plus	Catheter, angioplasty, peripheral, transluminal	56	9	6.7%
Admiral Xtreme Otw	Catheter, angioplasty, peripheral, transluminal	27	13	1%
Amphirion Deep Otw	Catheter, percutaneous	24	16	0%
In Pact Admiral Paclitaxel-Eluting Pta Balloon Catheter	Drug-eluting peripheral transluminal angioplasty catheter	12	104	6.5%
In Pact Pacific	Drug-eluting peripheral transluminal angioplasty catheter	3	0	0%
Complete Se Iliac	Stent, iliac	2	0	5%
Fortrex 0 035 Otw Pta Balloon Catheter	Catheter, angioplasty, peripheral, transluminal	1	29	0%
Spider Fx	Temporary carotid catheter for embolic capture	1	65	2%

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
LIT	Catheter, angioplasty, peripheral, transluminal	403	37.6%
DQY	Catheter, percutaneous	265	24.7%
NTE	Temporary carotid catheter for embolic capture	256	23.9%
FGE	Stents, drains and dilators for the biliary ducts	99	9.2%
NIO	Stent, iliac	17	1.6%
ONU	Drug-eluting peripheral transluminal angioplasty catheter	15	1.4%
DXE	Catheter, embolectomy	11	1%
NIP	Stent, superficial femoral artery	3	0.3%
DQX	Wire, guide, catheter	1	0.1%

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

Death6.1%65

Injury48.3%517

Malfunction45.2%484

Other0.5%5

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 Invatec reports

How many FDA device reports name Invatec as manufacturer?

1,071 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Admiral Xtreme (132), Amphirion Deep Pta Balloon Catheter (110), Pacific Xtreme (77), Pacific Plus (56) and Admiral Xtreme Otw (27).

Which device types does it report on?

catheter, angioplasty, peripheral, transluminal (37.6%), catheter, percutaneous (24.7%), temporary carotid catheter for embolic capture (23.9%) and stents, drains and dilators for the biliary ducts (9.2%).

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.