Device Report Trends
Download the CMS hospital extracts cited on this page: plainhospital-hospital-ratings.csv and plainhospital-state-summary.csv (CMS public records · CC0).
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 2024 and 2025. Across the 229 device types with at least 500 reports in both years, total reports moved from 2,520,985 to 2,750,902 (+9.1%), and 129 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.
Reports filed in 2026 are excluded: the federal extract behind this page was taken mid-year, so that year is incomplete and comparing it against a full year would show a fall for almost every device. 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, 2024 to 2025
Biggest decreases, 2024 to 2025
| # | Device type | 2024 | 2025 | Change | Percent |
|---|---|---|---|---|---|
| 1 | Reamer | 4,746 | 1,056 | -3,690 | -77.7% |
| 2 | Lens, Intraocular, Phakic | 2,148 | 659 | -1,489 | -69.3% |
| 3 | Automated Insulin Dosing , Threshold Suspend | 11,814 | 3,653 | -8,161 | -69.1% |
| 4 | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | 4,934 | 1,591 | -3,343 | -67.8% |
| 5 | Knife, Ophthalmic | 1,844 | 700 | -1,144 | -62.0% |
| 6 | Phakic Toric Intraocular Lens | 3,605 | 1,397 | -2,208 | -61.2% |
| 7 | Stapler, Skin | 1,275 | 518 | -757 | -59.4% |
| 8 | Mesh, Surgical, Polymeric | 8,581 | 3,574 | -5,007 | -58.3% |
| 9 | Aligner, Sequential | 8,992 | 4,578 | -4,414 | -49.1% |
| 10 | Temporary Non-Roller Type Left Heart Support Blood Pump | 18,592 | 9,878 | -8,714 | -46.9% |
| 11 | Programmer, Pacemaker | 1,545 | 827 | -718 | -46.5% |
| 12 | Coronavirus Antigen Detection Test System. | 1,406 | 755 | -651 | -46.3% |
| 13 | Temporary Non-Roller Type Right Heart Support Blood Pump | 1,031 | 554 | -477 | -46.3% |
| 14 | Detector And Alarm, Arrhythmia | 1,320 | 727 | -593 | -44.9% |
| 15 | Transducer, Ultrasonic, Diagnostic | 988 | 575 | -413 | -41.8% |
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. Incomplete extract year 2026 excluded.
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.