DRIVEMEDICAL CX418ADDA-ELRRecalls & reported problems
Drive Devilbiss Healthcare · Transport/WheelchairWheelchairs K4 Product Description: CruiserX4, 18" Adj DeskArm, ElvLg, 1/ea · Class 1
All models of DRIVEMEDICAL (111)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383528335), received between Dec 16, 2022 and Oct 26, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- Concussion2
- Convulsion/Seizure2
- Laceration(s)2
- Fall1
- Head Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 26, 2025Break; Break
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY THE PROVIDER WHO STATED THE END USER WAS SITTING IN THE WHEELCHAIR AND A WHEEL BROKE CAUSING THE END USER TO FALL TO THE FLOOR. THE END USER WAS HOSPITALIZED WITH A CONCUSSION, SEIZURES, AND A FOREARM SKIN TEAR. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Patient problems: Concussion; Convulsion/Seizure; Laceration(s)
MAUDE report 23387834 ↗InjuryOct 22, 2025Break; Break
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY THE PROVIDER WHO STATED THE END USER WAS SITTING IN THE WHEELCHAIR AND A WHEEL BROKE CAUSING THE END USER TO FALL TO THE FLOOR. THE END USER WAS HOSPITALIZED WITH A CONCUSSION, SEIZURES, AND A FOREARM SKIN TEAR. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Patient problems: Concussion; Convulsion/Seizure; Laceration(s)
MAUDE report 23356429 ↗InjuryDec 16, 2022Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY AN END USER'S HUSBAND, WHO STATED THAT THE END USER "FELL OUT OF CHAIR BACKWARDS AND BUMPED HER HEAD," CAUSING HER TO SUSTAIN INJURY FOR WHICH SHE IS RECEIVING PHYSICAL THERAPY. THE END USER'S HUSBAND ALSO REPORTED THAT UPON INSPECTION AT SOME POINT, THE SEAT UPHOLSTERY WAS RIPPED AND CHAIR HANDLE WAS BENT. THE END USER DECLINED TO RETURN THE PRODUCT FOR INSPECTION. DRIVE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Fall; Head Injury
MAUDE report 15995454 ↗
Other Wheelchair, mechanical devices
- MEDLINE K1186N22SMedline Industries, Inc. · Wheelchair, mechanical48 reports
- Guardian K4186N24EMedline Industries, Inc. · Wheelchair, mechanical22 reports
- MEDLINE INDUSTRIES, INC. MDS808650Medline Industries, Inc. · Wheelchair, mechanical18 reports
- Medline MDS806850Medline Industries, Inc. · Wheelchair, mechanical17 reports
- Quickie 7 SeriesSunrise Medical (US) LLC · Wheelchair, Mechanical1 death10 reports
- Guardian K3186N24EMedline Industries, Inc. · Wheelchair, mechanical10 reports
- Guardian K3206N24SMedline Industries, Inc. · Wheelchair, mechanical9 reports
- MEDLINE K3186N34SMedline Industries, Inc. · Wheelchair, mechanical9 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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