Device manufacturer, as written on reports

Covidien Medical Products: medical device reports filed with FDA

2,224 reports name it as the manufacturer of the device involved, 2010–2026.

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.

2,224
reports naming it as manufacturer: 0% of all MAUDE reports; 119
reports, 12 months to August 2026: 139 in the 12 months before; 78%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

2,224 medical device reports received by FDA give Covidien Medical Products as the manufacturer of the device involved, 0% of the MAUDE database, from November 2010 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

119 reports arrived in the 12 months to August 2026, down 14% from 139 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 (78%), injury (21.4%) and death (0.6%). 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
LigaSure Atlas	Electrosurgical, cutting & coagulation & accessories	415	16	0.7%
LigaSure	Electrosurgical, cutting & coagulation & accessories	343	879	0.2%
Emprint	Electrosurgical, cutting & coagulation & accessories	319	39	2.6%
Premium Plus Ceea	Staple, implantable	224	1	0.2%
Kangaroo	Pump, infusion, enteral	221	117	0.2%
Force Fx	Electrosurgical, cutting & coagulation & accessories	202	22	0.4%
Kendall SCD	Sleeve, limb, compressible	104	0	0%
Valleylab	Electrosurgical, cutting & coagulation & accessories	52	353	0.3%
Premium Plus Ceea 28 Instr W/Tilt-Top	Stapler, surgical	23	0	1.3%
Premium Plus Ceea 31 Instr W/Tilt-Top	Stapler, surgical	19	0	1.1%
Solitaire Fr4	Catheter, thrombus retriever	16	49	13.9%
Axium 3d	Device, vascular, for promoting embolization	12	48	1.6%
Eea	Staple, implantable	11	542	0.8%
Valleylab Ft10	Electrosurgical, cutting & coagulation & accessories	11	2	0.3%
Axium Helix	Device, vascular, for promoting embolization	7	24	3%
LigaSure Impact	Electrosurgical, cutting & coagulation & accessories	5	72	0.3%
React catheter	Catheter, percutaneous	3	41	18.4%
Parietex	Mesh, surgical, polymeric	2	320	1%
Unknown Ligasure Instrument	Electrosurgical, cutting & coagulation & accessories	2	35	8.1%
Cool-tip	Electrosurgical, cutting & coagulation & accessories	1	28	2%
Edge	Electrosurgical, cutting & coagulation & accessories	1	171	0.1%
Eea 31mm Single-Use Stapler	Staple, implantable	1	0	1.1%
ForceTriad	Electrosurgical, cutting & coagulation & accessories	1	13	0.2%
Shiley	Tube tracheostomy and tube cuff	1	1,513	1.1%
Unknown Eea	Staple, implantable	1	22	11.8%

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
GEI	Electrosurgical, cutting & coagulation & accessories	1,348	60.6%
GDW	Staple, implantable	293	13.2%
LZH	Pump, infusion, enteral	225	10.1%
NEY	System, ablation, microwave and accessories	194	8.7%
JOW	Sleeve, limb, compressible	113	5.1%
KRD	Device, vascular, for promoting embolization	20	0.9%
NRY	Catheter, thrombus retriever	16	0.7%
KNT	Tubes, gastrointestinal (and accessories)	6	0.3%
FRN	Pump, infusion	5	0.2%
LLZ	System, image processing, radiological	3	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

Death0.6%13

Injury21.4%477

Malfunction78%1,734

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 Covidien Medical Products reports

How many FDA device reports name Covidien Medical Products as manufacturer?

2,224 reports through August 2026, 119 of them in the latest 12 months.

Which of its brands appear most often?

LigaSure Atlas (415), LigaSure (343), Emprint (319), Premium Plus Ceea (224) and Kangaroo (221).

Which device types does it report on?

electrosurgical, cutting & coagulation & accessories (60.6%), staple, implantable (13.2%), pump, infusion, enteral (10.1%) and system, ablation, microwave and accessories (8.7%).

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.