Device manufacturer, as written on reports

Teleflex Medical: medical device reports filed with FDA

29,747 reports name it as the manufacturer of the device involved, 2004–2026.

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.

29,747
reports naming it as manufacturer: 0.1% of all MAUDE reports; 1,154
reports, 12 months to August 2026: 1,695 in the 12 months before; 96.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

29,747 medical device reports received by FDA give Teleflex Medical as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2004 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,154 reports arrived in the 12 months to August 2026, down 32% from 1,695 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 malfunction (96.7%), injury (2.5%) and death (0.4%). 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
Auto Endo5 Ml	Clip, implantable	2,007	22	0%
Visistat 35w 6/Box	Staple, removable (skin)	1,717	3	0%
Weck Visistat Skin Stapler 35r	Stapler, skin	1,270	26	0%
Visistat 35r 6/Box	Stapler, skin	1,042	0	0%
Hudson Concha Neptune	Humidifier, respiratory gas, (direct patient interface)	771	0	0.1%
Weck Visistat Skin Stapler 35w	Stapler, skin	681	49	0%
Weck Hol Ml 5mm Endo Applier	Applier, surgical, clip	566	306	0%
Hemolok Ml Clips 6/Cart 84/Box	Clip, implantable	534	0	0.2%
Hol Ml 5mm Endo Applier	Applier, surgical, clip	446	0	0%
Weck Visistat 35r 6/Box	Stapler, skin	442	47	0%
Weck Visistat 35w 6/Box	Stapler, skin	410	167	0%
Ez-Io Power Driver	Needle, hypodermic, single lumen	391	0	2.2%
Hudson Micro Mist Nebulizer W/Elong	Nebulizer (direct patient interface)	249	0	0%
Hemolok L Clips 6/Cart 84/Box	Clip, implantable	226	0	0%
Extraction Bag For Mis	Laparoscope, general & plastic surgery	203	9	0%
Weck Auto Endo5 Ml	Clip, implantable	195	75	0%
Hudson Nebulizer Adaptor 033 Sterile Japanese	Nebulizer (direct patient interface)	160	0	0%
Visistat Skin Stapler 35w	Staple, removable (skin)	154	0	0%
Arrow	System, balloon, intra-aortic and control	16	65	3.4%
Rusch	Catheter, urological	10	0	1.8%

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
FZP	Clip, implantable	4,275	14.4%
QQS	Stapler, skin	3,753	12.6%
GDT	Staple, removable (skin)	2,674	9%
BTR	Tube, tracheal (w/wo connector)	2,517	8.5%
GDO	Applier, surgical, clip	1,764	5.9%
BTT	Humidifier, respiratory gas, (direct patient interface)	1,489	5%
CAF	Nebulizer (direct patient interface)	1,158	3.9%
CCW	Laryngoscope, rigid	1,034	3.5%
FMI	Needle, hypodermic, single lumen	807	2.7%
EZL	Catheter, retention type, balloon	524	1.8%

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

Death0.4%106

Injury2.5%752

Malfunction96.7%28,762

Other0.3%87

Not given0.1%40

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

Questions about Teleflex Medical reports

How many FDA device reports name Teleflex Medical as manufacturer?

29,747 reports through August 2026, 1,154 of them in the latest 12 months.

Which of its brands appear most often?

Auto Endo5 Ml (2,007), Visistat 35w 6/Box (1,717), Weck Visistat Skin Stapler 35r (1,270), Visistat 35r 6/Box (1,042) and Hudson Concha Neptune (771).

Which device types does it report on?

clip, implantable (14.4%), stapler, skin (12.6%), staple, removable (skin) (9%) and tube, tracheal (w/wo connector) (8.5%).

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.