FDA MAUDE · DEVICE SAFETY RESEARCH
Emerging device signals
Explore reported injuries, device problems and reporting changes as leads for further investigation.
Research leads, not predicted cases. MAUDE is a passive reporting system. Reports may be incomplete, delayed, duplicated or unverified. Counts do not establish injury rates, causation, liability, eligible claimants or future lawsuits. Reports may involve events outside the United States. Compare with recalls, studies and primary court records.
Report entries · 90 days
1,073,547Full API-index count, not the pilot sampleReports classified as injury
325,265Reported event type; not verified injured peopleReports classified as death
3,171Reported event type; causation unverifiedPrior 90-day report entries
854,3462026-03-05 – 2026-06-02Latest available receipt: 2026-08-31. The dataset can lag today. The latest month is shown only through this date.
12-month reporting activity
FDA receipt month · report entries, not event dates or people
View monthly numbers
| 2025-09 | 258,044 |
|---|---|
| 2025-10 | 256,791 |
| 2025-11 | 232,947 |
| 2025-12 | 261,274 |
| 2026-01 | 290,252 |
| 2026-02 | 248,222 |
| 2026-03 | 273,144 |
| 2026-04 | 303,173 |
| 2026-05 | 291,552 |
| 2026-06 | 328,804 |
| 2026-07 | 343,264 |
| 2026-08 | 425,317 |
Reported event types
Current 90-day receipt window
A malfunction report may describe no patient injury. FDA report totals are not a count of viable legal claims.
DEVICE RESEARCH SHORTLIST
Products to investigate
API-index report counts, not a 500-report sample. Product panel: top 12 codes by recent report volume plus LGW, FDT, FTM and OTN. This panel is not an exhaustive ranking of all devices. Multi-valued device and problem fields overlap.
| Device / product code | 90 days | Prior 90 | Change | Injury | Death | Research lead |
|---|---|---|---|---|---|---|
| Set, Administration, IntravascularFPA | 91,610 | 49,702 | +84.3% | 30,714 | 347 | Reporting increase · investigate |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery SystemsQLG | 59,712 | 6,972 | +756.5% | 756 | 1 | Reporting increase · investigate |
| Ventilator, Non-Continuous (Respirator)BZD | 23,685 | 12,860 | +84.2% | 31 | 1 | Reporting increase · investigate |
| Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-InitiatedPZE | 18,038 | 838 | +2052.5% | 145 | 0 | Reporting increase · investigate |
| Alternate Controller Enabled Insulin Infusion PumpQFG | 108,645 | 96,355 | +12.8% | 15,013 | 82 | Death reports · review source evidence |
| Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW | 7,918 | 8,065 | -1.8% | 6,399 | 78 | Death reports · review source evidence |
| Integrated Continuous Glucose Monitoring System, Factory CalibratedQBJ | 206,096 | 145,158 | +42.0% | 5,230 | 37 | Death reports · review source evidence |
| Pump, InfusionFRN | 12,304 | 14,437 | -14.8% | 201 | 24 | Death reports · review source evidence |
| Automated Insulin Dosing Device System, Single Hormonal ControlOZP | 24,700 | 27,971 | -11.7% | 1,609 | 11 | Death reports · review source evidence |
| Duodenoscope And Accessories, Flexible/RigidFDT | 2,884 | 2,586 | +11.5% | 42 | 3 | Monitor reported device problems |
| Cabinet, Table And Tray, AnesthesiaBRY | 17,067 | 13,916 | +22.6% | 2 | 2 | Monitor reported device problems |
| Implant, Endosseous, Root-FormDZE | 196,123 | 181,826 | +7.9% | 195,874 | 1 | Injury reports · review source evidence |
| Mesh, SurgicalFTM | 77 | 23 | Baseline too small | 67 | 1 | Monitor reported device problems |
| Gastroscope And Accessories, Flexible/RigidFDS | 9,946 | 9,888 | +0.6% | 9 | 1 | Monitor reported device problems |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN | 18 | 52 | -65.4% | 14 | 0 | Monitor reported device problems |
| Pacemaker/Icd/Crt Non-Implanted ComponentsOSR | 17,750 | 24,423 | -27.3% | 10 | 0 | Monitor reported device problems |
Priority is a transparent review heuristic: reporting increases require at least 30 prior reports, 100 current reports, 50% growth and 25 injury/death reports. Otherwise, 10 death reports or 100 injury reports prompt source review. No statistical significance, clinical risk or case-value score is assigned. Changes in use, reporting practices and manufacturer submissions may explain changes.
Reported patient problems
Reported labels can include no clinical symptoms; categories overlap
Reported device problems
Technical failure modes are separate from injuries
Brands appearing in reports
Raw source names; aliases are not merged and counts overlap
Manufacturers appearing in reports
Raw source names; not a safety ranking
Free automated openFDA collection runs daily; unchanged FDA releases retain the last snapshot. FDA dataset documentation · MAUDE search. Last source check: 2026-10-09 21:59 UTC.