Empulse R90Recalls & reported problems
Sunrise Medical (US) LLC · The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00016958059465), received between Mar 20, 2026 and Mar 20, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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
- Use of Device Problem1
Patient problems
- Damage to Ligament(s)1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Mechanical Problem; Use of Device Problem
A COMPLAINT WAS RECEIVED INVOLVING A POWERED ADD-ON UNIT USED WITH WHEELCHAIR DURING DOWNHILL TRAVEL. THE USER REPORTED THAT THE CONTROL SWITCH DID NOT RESPOND, RESULTING IN UNINTENDED ACCELERATION. ATTEMPTS TO STOP THE DEVICE USING THE CONTROL INTERFACE AND MANUAL BRAKING METHODS WERE REPORTEDLY UNSUCCESSFUL. DURING THE EVENT, THE USER LOST CONTROL, LEADING TO A FALL AND A REPORTED LIGAMENT INJURY REQUIRING MEDICAL EVALUATION. ADDITIONAL INFORMATION INDICATES THE UNIT REMAINED FUNCTIONAL AFTER THE INCIDENT, AND THE USER CONTINUES TO OPERATE IT. PRELIMINARY FOLLOW-UP SUGGESTS RECENT BATTERY REPLACEMENT IN THE CONTROL UNIT, THOUGH NO CLEAR ROOT CAUSE HAS BEEN IDENTIFIED. FURTHER INVESTIGATION IS ONGOING, INCLUDING EVALUATION OF DEVICE PERFORMANCE, OPERATING CONDITIONS (E.G., SLOPE), AND PRIOR USAGE HISTORY.
Patient problems: Damage to Ligament(s); Pain
MAUDE report 24650222 ↗
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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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