Carevo BAC1101-01Recalls & reported problems
Arjohuntleigh AB · Carevo, - shower trolley · Class 1
All models of Carevo (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05055982787161), received between Sep 29, 2023 and Sep 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Fell” (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
- Device Fell1
- Fracture1
Patient problems
- Fall1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fracture
Arjo was notified of an issue related to the Carevo shower trolley. It was reported that the locking mechanism of the Carevo side support was not functioning properly. During the device inspection performed by an Arjo technician, it was found that the side support handle had broken off. The circumstances under which the malfunction occurred are unknown. No patient involvement or injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894415 ↗MalfunctionSep 29, 2023Device Fell; Device Fell
ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF A CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT A RESIDENT FELL OUT OF THE DEVICE. AT THE TIME OF TURNING THE RESIDENT TO THE RIGHT SIDE, THE SIDE SUPPORT OPENED. THE RESIDENT SUFFERED A NECK PAIN (CERVICALGIA) AND WAS TREATED WITH CERVICAL COLLAR.
Patient problems: Fall; Pain
MAUDE report 17842171 ↗
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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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