Device Report Trends

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Which medical device types saw the biggest change in adverse-event reports filed with the U.S. Food and Drug Administration through its MAUDE database, between 2025 and 2026. Across the 202 device types with at least 500 reports in both years, total reports moved from 2,732,356 to 1,981,139 (-27.5%), and 21 of them rose. The counts come from the same per-year totals shown on each device page, and the derivation is in our methodology.

A rise here is not evidence a device became more dangerous. Report volume follows how widely a device is used and how closely it is being watched: a recall, a new product launch, a lawsuit, or a change in FDA reporting requirements each move these counts without any change in the device itself. MAUDE reports are unverified submissions and do not establish that a device caused the event described.

Devices below 500 reports in either year are excluded too, because a percentage computed from a handful of reports says nothing. How to read this data: understanding FDA device reports.

Biggest increases, 2025 to 2026

# Device type 20252026ChangePercent
1 Pacemaker/Icd/Crt Non-Implanted Components 8,600 45,147 +36,547 +425.0%
2 Set, Administration, Intravascular 35,052 106,588 +71,536 +204.1%
3 Drills, Burrs, Trephines & Accessories (Simple, Powered) 1,943 5,289 +3,346 +172.2%
4 Ureteroscope And Accessories, Flexible/Rigid 1,320 2,412 +1,092 +82.7%
5 Ventilator, Continuous, Non-Life-Supporting 1,810 3,183 +1,373 +75.9%
6 Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated 1,592 2,798 +1,206 +75.8%
7 Abutment, Implant, Dental, Endosseous 850 1,481 +631 +74.2%
8 Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate 1,173 2,024 +851 +72.5%
9 Ultrasound Bronchoscope 1,491 2,284 +793 +53.2%
10 Duodenoscope And Accessories, Flexible/Rigid 3,985 6,083 +2,098 +52.6%
11 Cystoscope And Accessories, Flexible/Rigid 2,701 4,042 +1,341 +49.6%
12 Endoscopic Ultrasound System, Gastroenterology-Urology 3,581 4,924 +1,343 +37.5%
13 Colonoscope And Accessories, Flexible/Rigid 17,411 23,142 +5,731 +32.9%
14 Nasopharyngoscope (Flexible Or Rigid) 1,356 1,783 +427 +31.5%
15 Gastroscope And Accessories, Flexible/Rigid 19,078 24,200 +5,122 +26.8%

Biggest decreases, 2025 to 2026

# Device type 20252026ChangePercent
1 Interventional Fluoroscopic X-Ray System 14,140 2,849 -11,291 -79.9%
2 Neurological Stereotaxic Instrument 3,484 921 -2,563 -73.6%
3 Automated Insulin Dosing , Threshold Suspend 3,653 966 -2,687 -73.6%
4 Device, Hemostasis, Vascular 12,862 3,466 -9,396 -73.1%
5 Catheter, Urological (Antimicrobial) And Accessories 3,809 1,090 -2,719 -71.4%
6 Replacement Heart-Valve 3,156 973 -2,183 -69.2%
7 System, X-Ray, Angiographic 2,204 730 -1,474 -66.9%
8 Catheter, Steerable 4,085 1,469 -2,616 -64.0%
9 Laryngoscope, Rigid 1,578 584 -994 -63.0%
10 Sensor, Glucose, Invasive, Non-Adjunctive 38,645 14,465 -24,180 -62.6%
11 Needle, Hypodermic, Single Lumen 2,465 926 -1,539 -62.4%
12 Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation 1,432 585 -847 -59.1%
13 Set, Administration, For Peritoneal Dialysis, Disposable 2,491 1,049 -1,442 -57.9%
14 Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 4,424 1,891 -2,533 -57.3%
15 Catheters, Transluminal Coronary Angioplasty, Percutaneous 1,922 834 -1,088 -56.6%

What moves these numbers

MAUDE counts reports, not incidents and not injuries. One event can generate several reports, and many events generate none. Manufacturers, hospitals and importers are required to report; patients and clinicians may report voluntarily, so a device with an active user community can accumulate reports faster than a comparable device without one.

The largest year-over-year swings usually have an administrative cause rather than a clinical one. A manufacturer that begins filing a backlog, a device that reaches a new market, a recall that prompts retrospective filings, or a change in how a product family is coded will all show up here as movement. Reading a number on this page as a safety verdict is the mistake it is designed to prevent.

Every count comes from the same per-year report totals shown on each device page, so a figure here and a figure there cannot disagree. The full derivation is in the methodology.

Source: U.S. Food and Drug Administration (FDA) MAUDE, Manufacturer and User Facility Device Experience · August 2026 Year-over-year change computed by PlainHospital from per-year report totals.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Change is computed between the two most recent COMPLETE report years; an incomplete extract year is excluded rather than compared against a full one. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.