MERITS P3278-ARMUBRecalls & reported problems
Merits Health Products CO., Ltd. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04714379298550), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K012802); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Mechanical Problem; Mechanical Problem
CUSTOMER STATES THE UNIT SEAT BECAME UNLATCHED AND WENT FORWARD WHILE DRIVING, UPON FURTHER INSPECTION, THE CLAMP IN THE BACK WAS NOT LOCKED IN.
Patient problems: Fall
MAUDE report 22737669 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012802. One submission often covers many models, so check the product and lot details in each record.
- Z-1504-2021 · Apr 1, 2021 · Open, ClassifiedPower Wheelchair
Other Wheelchair, Powered devices
- SmartDrive® MX2+Max Mobility, LLC · Wheelchair, Powered858 reports
- Permobil M3Permobil, Inc. · Wheelchair, Powered1 recall59 reports
- TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx TDXSP2-MCGInvacare Corporation · Wheelchair, powered2 recalls2 reports
- TDX SP2 with LiNX Electronics TDXSP2Invacare Corporation · Wheelchair, powered2 recalls0 reports
- Invacare® TDX SP2 with Captain's Seat TDXSP2VInvacare Corporation · Wheelchair, powered2 recalls0 reports
- Q6 Edge 3Pride Mobility Products Corp · Wheelchair, Powered4 deaths86 reports
- Q6 Edge 2.0 Q6 Edge 2.0 / Q6 Edge 2.0 with iLevelPride Mobility Products Corp · Wheelchair, Powered1 death83 reports
- Permobil M5Permobil, Inc. · Wheelchair, Powered1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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