Covidien medical device reports that give this manufacturer
- Name type
- Device manufacturer, as written on reports
What a report is
A report is not proof that the device was the cause of the event.
FDA says:
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.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
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.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
From April 2007 to September 2026, FDA received 67,119 medical device reports that give Covidien as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.
FDA received 7,583 reports in the 12 months to September 2026 and 4,175 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 7,583 (0.2%) give Covidien as the manufacturer. Manufacturer reports were 89.4% of the reports that name this manufacturer and 94.9% of all device reports.
The number of people who use the product is not in the data. A count is not a rate.
Why manufacturers report
FDA says:
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .
Data version
openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.
Brand names
The table has the 96 brand pages with 5 or more reports that give this manufacturer. 98 brand pages have a report in all. The rows are in order of name. A brand page with fewer reports is not in the table.
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Brand name | Product code | Reports | Reports, 12 months to September 2026 |
|---|---|---|---|
| 3 5fr Urethane Umb Cath | Catheter, umbilical artery | 157 | 0 |
| 3611 Lite Glove | Patient examination glove | 143 | 0 |
| 3612 Lite Glove | Patient examination glove | 128 | 0 |
| 5 5mm Short Secondary Port | Laparoscope, general & plastic surgery | 53 | 0 |
| 840 Ventilator | Ventilator, continuous, facility use | 7,769 | 25 |
| 980 Ventilator | Ventilator, continuous, facility use | 4,593 | 93 |
| Abre Venous Self-Expanding Stent System | Stent, iliac vein | 286 | 76 |
| Argyle | Catheter, peritoneal, long-term indwelling | 325 | 53 |
| Auto Suture | Laparoscope, general & plastic surgery | 245 | 226 |
| Autosuture | Stapler, surgical | 5 | 0 |
| Bis | Index-generating electroencephalograph software | 139 | 108 |
| Closurefast Catheter | Electrosurgical, cutting & coagulation & accessories | 543 | 105 |
| Covidien | Mesh, surgical, polymeric | 101 | 25 |
| Dar | Catheters, suction, tracheobronchial | 98 | 76 |
| Dialysis Unknown | Catheter, peritoneal, long-term indwelling | 141 | 3 |
| Dover | Catheter, urological | 13 | 31 |
| Edge | Electrosurgical, cutting & coagulation & accessories | 209 | 159 |
| Eea | Staple, implantable | 633 | 513 |
| Endo Catch Gold | Laryngoscope, endoscope | 12 | 87 |
| Endo Catch Gold 10mm Specimen Pouch Intl | Laryngoscope, endoscope | 300 | 0 |
| Endo GIA | Staple, implantable | 1,682 | 1,954 |
| Endo GIA Ultra | Staple, implantable | 1,480 | 1,060 |
| Endo Stitch | Endoscopic tissue approximation device | 186 | 64 |
| Endo Stitch 10mm Suturing Device | 1,044 | 0 | |
| Epump 1000ml Safety Screw Spik | Pump, infusion, enteral | 1,059 | 0 |
| Evercross 035 | Catheter, angioplasty, peripheral, transluminal | 360 | 26 |
| Everflex Self-Expanding Peripheral Stent With Entrust Delivery System Long | Stent, superficial femoral artery | 314 | 26 |
| Everflex Self-Expanding Peripheral Stent With Entrust Delivery System Standard | Stent, superficial femoral artery | 125 | 15 |
| Forcetriad Energy Platform | Electrosurgical, cutting & coagulation & accessories | 198 | 0 |
| Fortrex 0 035 Otw Pta Balloon Catheter | Catheter, angioplasty, peripheral, transluminal | 131 | 34 |
| Gia | Staple, implantable | 303 | 380 |
| Ht70 Plus Ventilator | Ventilator, continuous, facility use | 38 | 0 |
| Invos | Oximeter, tissue saturation | 41 | 56 |
| Kangaroo | Pump, infusion, enteral | 3,279 | 110 |
| Kangaroo Epump - New | Pump, infusion, enteral | 601 | 0 |
| Kangaroo Epump - Rfb | Pump, infusion, enteral | 120 | 0 |
| Kangaroo Joey Pump W/Pole Clmp | Pump, infusion, enteral | 545 | 0 |
| Kangaroo Joeypump W/Pole Clmp | Pump, infusion, enteral | 111 | 0 |
| Kendall SCD | Sleeve, limb, compressible | 33 | 0 |
| LigaSure | Electrosurgical, cutting & coagulation & accessories | 1,438 | 868 |
| Ligasure Advance | Electrosurgical, cutting & coagulation & accessories | 11 | 0 |
| Ligasure Advance Pistol Grip | Electrosurgical, cutting & coagulation & accessories | 736 | 0 |
| Ligasure Atlas Handswitching 37cm | Electrosurgical, cutting & coagulation & accessories | 19 | 0 |
| Ligasure Blunt Tip Laparoscopic Sealer/Divider | Electrosurgical, cutting & coagulation & accessories | 150 | 0 |
| LigaSure Impact | Electrosurgical, cutting & coagulation & accessories | 224 | 72 |
| Ligasure Impact Lf4318 | Electrosurgical, cutting & coagulation & accessories | 127 | 0 |
| Ligasure Impact Thoracic | Electrosurgical, cutting & coagulation & accessories | 19 | 0 |
| Ligasure Precise | Electrosurgical, cutting & coagulation & accessories | 37 | 0 |
| LigaSure XP | Electrosurgical, cutting & coagulation & accessories | 255 | 186 |
| Magellan | Needle, hypodermic, single lumen | 157 | 16 |
| Mahurkar | Catheter, hemodialysis, non-implanted | 190 | 2 |
| Mahurkar Elite | Catheter, hemodialysis, non-implanted | 30 | 9 |
| Mallinckrodt | Tube, tracheal (w/wo connector) | 1,462 | 1 |
| Maryland Jaw Lap 37cm | Electrosurgical, cutting & coagulation & accessories | 197 | 0 |
| McGRATH MAC | Laryngoscope, rigid | 142 | 150 |
| Microvascular Plug | Device, vascular, for promoting embolization | 24 | 11 |
| Monoject | Syringe, piston | 210 | 14 |
| N595 Pulse Oximeter | Oximeter | 7 | 0 |
| Nanocross 0 14 Otw Pta Dilatation Catheter | Catheter, angioplasty, peripheral, transluminal | 90 | 20 |
| Nanocross Elite 0 14 Otw Pta Dilatation Catheter | Catheter, angioplasty, peripheral, transluminal | 75 | 17 |
| Nellcor | Oximeter | 243 | 204 |
| New Ligasure 5mm | Electrosurgical, cutting & coagulation & accessories | 337 | 0 |
| Nim Emg - Endotracheal Tube - Trivantage | Stimulator, nerve | 52 | 218 |
| Nim Probe | Stimulator, nerve | 35 | 70 |
| Oximax N-595 Pulse Oximeter | Oximeter | 12 | 0 |
| Palindrome | Catheter, hemodialysis, implanted | 544 | 38 |
| Pdb | Laparoscope, general & plastic surgery | 233 | 176 |
| Pipeline Embolization Device | Intracranial aneurysm flow diverter | 131 | 0 |
| Polyhesive Return Electrode | Electrosurgical, cutting & coagulation & accessories | 64 | 0 |
| Protack | Laparoscope, general & plastic surgery | 28 | 41 |
| Protege Everflex Self-Expanding Stent System Long | Stents, drains and dilators for the biliary ducts | 129 | 27 |
| Protege Everflex Self-Expanding Stent System Standard | Stents, drains and dilators for the biliary ducts | 163 | 20 |
| Protege Gps Self-Expanding Stent System 035 Standard | Stents, drains and dilators for the biliary ducts | 85 | 8 |
| Protege Rx Carotid Stent System | Stent, carotid | 394 | 55 |
| Puritan Bennett | Ventilator, continuous, facility use | 114 | 10 |
| Scd 700 Compression System-Us | Sleeve, limb, compressible | 90 | 0 |
| Shiley | Tube tracheostomy and tube cuff | 999 | 1,434 |
| Situate | Gauze/sponge, internal, x-ray detectable | 31 | 46 |
| Sonicision | Instrument, ultrasonic surgical | 183 | 134 |
| Spacemaker | Laparoscope, general & plastic surgery | 191 | 160 |
| Spider Fx | Temporary carotid catheter for embolic capture | 633 | 65 |
| Spiderfx Embolic Protection Device | Temporary carotid catheter for embolic capture | 19 | 0 |
| Strata | Shunt, central nervous system and components | 248 | 155 |
| Ta | Staple, implantable | 188 | 139 |
| Tri-Staple 2.0 | Staple, implantable | 11 | 619 |
| Tumescent Infiltration Pump | Pump, infusion | 97 | 0 |
| Ultrasonic Dissector | Instrument, ultrasonic surgical | 385 | 0 |
| Unknown Prefill | Heparin, vascular access flush | 170 | 0 |
| V-Loc 180 | Suture, absorbable, synthetic, polyglycolic acid | 12 | 658 |
| Valleylab | Electrosurgical, cutting & coagulation & accessories | 462 | 344 |
| Vena Seal Closure System | Agent, occluding, vascular, permanent | 31 | 83 |
| Visi-Pro Balloon-Expandable Stent System | Stent, iliac | 245 | 22 |
| Vistec | Gauze/sponge, internal, x-ray detectable | 202 | 25 |
| Xps Blade | Bur, ear, nose and throat | 26 | 59 |
| Xps Bur | Bur, ear, nose and throat | 13 | 12 |
| Xps System Navigated Blade | Bur, ear, nose and throat | 35 | 11 |
Device types
The table has the 43 device types with 5 or more reports that give this manufacturer. The rows are in order of name.
FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Reports by month
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Event type
| Event type | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 707 | 1.1% | |
| Injury | 11,446 | 17.1% | |
| Malfunction | 54,095 | 80.6% | |
| Other | 642 | 1% | |
| Not given | 229 | 0.3% |
The event type is the classification that the reporter gave. FDA does not verify it.
Official pages
- Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. Covidien: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/covidien/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.
The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Does a large count say something about the manufacturer?
Not by itself. FDA says:
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
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.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
What event types do the reports record?
Death (707), injury (11,446), malfunction (54,095) and other (642). The event type is the classification that the reporter gave. FDA does not verify it.
Why can one company have more than one page?
The manufacturer field is free text on the report. This page counts the 67,119 reports with the name Covidien after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.