Device manufacturer, as written on reports

Covidien: medical device reports filed with FDA

66,777 reports name it as the manufacturer of the device involved, 2007–2026.

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.

66,777
reports naming it as manufacturer: 0.3% of all MAUDE reports; 7,914
reports, 12 months to August 2026: 3,671 in the 12 months before; 80.5%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

66,777 medical device reports received by FDA give Covidien as the manufacturer of the device involved, 0.3% of the MAUDE database, from April 2007 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

7,914 reports arrived in the 12 months to August 2026, up 116% from 3,671 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 (80.5%), injury (17.1%) and death (1.1%). 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
840 Ventilator	Ventilator, continuous, facility use	7,769	27	0.4%
980 Ventilator	Ventilator, continuous, facility use	4,593	117	0.2%
Kangaroo	Pump, infusion, enteral	3,279	117	0.2%
Endo GIA	Staple, implantable	1,653	2,086	0.3%
Mallinckrodt	Tube, tracheal (w/wo connector)	1,462	1	1.2%
Endo GIA Ultra	Staple, implantable	1,430	1,116	0.1%
LigaSure	Electrosurgical, cutting & coagulation & accessories	1,388	879	0.2%
Epump 1000ml Safety Screw Spik	Pump, infusion, enteral	1,059	0	0%
Endo Stitch 10mm Suturing Device	—	1,044	0	0%
Shiley	Tube tracheostomy and tube cuff	999	1,513	1.1%
Ligasure Advance Pistol Grip	Electrosurgical, cutting & coagulation & accessories	736	0	0%
Spider Fx	Temporary carotid catheter for embolic capture	627	65	2%
Eea	Staple, implantable	615	542	0.8%
Kangaroo Epump - New	Pump, infusion, enteral	601	0	0.2%
Kangaroo Joey Pump W/Pole Clmp	Pump, infusion, enteral	545	0	0.4%
Palindrome	Catheter, hemodialysis, implanted	544	52	1.3%
Closurefast Catheter	Electrosurgical, cutting & coagulation & accessories	543	108	0.5%
Valleylab	Electrosurgical, cutting & coagulation & accessories	451	353	0.3%
Protege Rx Carotid Stent System	Stent, carotid	390	54	6.3%
Ultrasonic Dissector	Instrument, ultrasonic surgical	385	0	0.2%
Evercross 035	Catheter, angioplasty, peripheral, transluminal	360	30	2.6%
New Ligasure 5mm	Electrosurgical, cutting & coagulation & accessories	337	0	0.4%
Argyle	Catheter, peritoneal, long-term indwelling	325	60	1%
Everflex Self-Expanding Peripheral Stent With Entrust Delivery System Long	Stent, superficial femoral artery	314	26	0.5%
Endo Catch Gold 10mm Specimen Pouch Intl	Laryngoscope, endoscope	300	0	0%
Gia	Staple, implantable	297	404	0.9%
Abre Venous Self-Expanding Stent System	Stent, iliac vein	284	78	1.6%
Strata	Shunt, central nervous system and components	248	163	2.2%
Visi-Pro Balloon-Expandable Stent System	Stent, iliac	245	24	4.1%
LigaSure XP	Electrosurgical, cutting & coagulation & accessories	238	177	0%

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
CBK	Ventilator, continuous, facility use	13,104	19.6%
GEI	Electrosurgical, cutting & coagulation & accessories	8,147	12.2%
LZH	Pump, infusion, enteral	6,761	10.1%
GDW	Staple, implantable	4,227	6.3%
GCJ	Laparoscope, general & plastic surgery	1,964	2.9%
MSD	Catheter, hemodialysis, implanted	1,963	2.9%
KNT	Tubes, gastrointestinal (and accessories)	1,243	1.9%
GAG	Stapler, surgical	1,046	1.6%
LIT	Catheter, angioplasty, peripheral, transluminal	1,023	1.5%
FMI	Needle, hypodermic, single lumen	946	1.4%

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

Death1.1%707

Injury17.1%11,427

Malfunction80.5%53,774

Other1%640

Not given0.3%229

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

Questions about Covidien reports

How many FDA device reports name Covidien as manufacturer?

66,777 reports through August 2026, 7,914 of them in the latest 12 months.

Which of its brands appear most often?

840 Ventilator (7,769), 980 Ventilator (4,593), Kangaroo (3,279), Endo GIA (1,653) and Mallinckrodt (1,462).

Which device types does it report on?

ventilator, continuous, facility use (19.6%), electrosurgical, cutting & coagulation & accessories (12.2%), pump, infusion, enteral (10.1%) and staple, implantable (6.3%).

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.