Carevo BAC1111-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05055982787178), received between Jun 11, 2019 and Feb 9, 2026 — classified as 2 deaths, 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Fell” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Device Fell

  ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A CAREVO SHOWER LIFT TROLLEY. IT WAS REPORTED THAT A PATIENT WAS TURNED ONTO THEIR LEFT SIDE SO THAT THE CAREGIVER COULD POSITION THE SLING. AT THAT MOMENT, THE SIDE SUPPORT OF THE CAREVO OPENED, AND THE PATIENT FELL. AS A RESULT, THE PATIENT SUSTAINED A BROKEN NOSE AND REQUIRED SIXTEEN STITCHES. IT WAS ALSO INDICATED THAT SEVERAL LATERAL MOBILIZATIONS HAD BEEN PERFORMED BEFORE THE FALL. THE DEVICE WAS SUBSEQUENTLY INSPECTED BY AN ARJO TECHNICIAN, WHO FOUND NO MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE EVENT. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE CAREGIVER HAD CLOSED THE SIDE SUPPORT WITH ONE HAND WHILE THE PATIENT WAS ALREADY POSITIONED IN THE CAREVO. IN THIS SITUATION, ONLY THE HANDLE LOCATED AT THE FOOT END CAN ENGAGE PROPERLY, MAKING IT POSSIBLE FOR THE PATIENT TO ACCIDENTALLY OPEN IT WITH THEIR FOOT WHILE LYING ON THEIR SIDE. FURTHERMORE, THE PATIENT¿S LEGS WERE OUTSIDE THE CAREVO, AND IT IS LIKELY THAT SHE MAY HAVE TOUCHED THE HANDLE WITH HER HEEL.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24289481 ↗
• InjuryFeb 9, 2026Device Fell

  ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A CAREVO SHOWER LIFT TROLLEY. IT WAS REPORTED THAT A PATIENT WAS TURNED ONTO THEIR LEFT SIDE SO THAT THE CAREGIVER COULD POSITION THE SLING. AT THAT MOMENT, THE SIDE SUPPORT OF THE CAREVO OPENED, AND THE PATIENT FELL. AS A RESULT, THE PATIENT SUSTAINED A BROKEN NOSE AND REQUIRED SIXTEEN STITCHES. IT WAS ALSO INDICATED THAT SEVERAL LATERAL MOBILIZATIONS HAD BEEN PERFORMED BEFORE THE FALL. THE DEVICE WAS SUBSEQUENTLY INSPECTED BY AN ARJO TECHNICIAN, WHO FOUND NO MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE EVENT. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE CAREGIVER HAD CLOSED THE SIDE SUPPORT WITH ONE HAND WHILE THE PATIENT WAS ALREADY POSITIONED IN THE CAREVO. IN THIS SITUATION, ONLY THE HANDLE LOCATED AT THE FOOT END CAN ENGAGE PROPERLY, MAKING IT POSSIBLE FOR THE PATIENT TO ACCIDENTALLY OPEN IT WITH THEIR FOOT WHILE LYING ON THEIR SIDE. FURTHERMORE, THE PATIENT¿S LEGS WERE OUTSIDE THE CAREVO, AND IT IS LIKELY THAT SHE MAY HAVE TOUCHED THE HANDLE WITH HER HEEL.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 24289477 ↗
• MalfunctionSep 3, 2025Use of Device Problem; Insufficient Device Problem Information; Device Fell; Use of Device Problem; Insufficient Device Problem Information; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING THE CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT WHILE TURNING A RESIDENT ON THE DEVICE, THE RESIDENT FELL OFF THE CAREVO ONTO THE FLOOR. A STAFF MEMBER ON THAT SIDE HELPED BREAK THE RESIDENT¿S FALL. ACCORDING TO THE STAFF, THE SIDE SUPPORTS WERE IN PLACE IN THE SPLAYED SETTING BUT COLLAPSED WHEN THE RESIDENT¿S WEIGHT WAS APPLIED TO THE SIDE. THE RESIDENT WAS TAKEN TO THE HOSPITAL AND LATER DISCHARGED. NO INJURIES WERE REPORTED.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950264 ↗
• MalfunctionJul 30, 2025Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN INCIDENT REGARDING THE CAREVO SHOWER TROLLEY. THE RESIDENT WAS POSITIONED ON THE LIFT. DUE TO THE RESIDENT'S WEIGHT AND SIZE, THEY WERE PLACED ON THEIR SIDE FOR HYGIENIC REASONS, WITH THEIR BODY RESTING ON THE SIDE SUPPORTS. WHILE BEING TURNED, THE LEFT SIDE SUPPORT SUDDENLY OPENED, MOST LIKELY BECAUSE THE LATCH HAD NOT LOCKED INTO THE GROOVE. THE RESIDENT SLID DOWN INTO THE KNEES OF THE STAFF MEMBER, WHO MANAGED TO CATCH THEM. NEITHER THE STAFF MEMBER NOR THE RESIDENT SUSTAINED ANY INJURIES.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22661387 ↗
• MalfunctionMar 27, 2025Fracture; Device Fell; Fracture; Device Fell

  ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A CAREVO SHOWER LIFT TROLLEY. THE INCIDENT OCCURRED DURING A PATIENT'S TREATMENT WHILE THE PATIENT WAS CHANGING POSITION TO THE SIDE OF THE CAREVO. IT WAS INDICATED THAT THE SIDE SUPPORT BROKE DOWN, CAUSING THE PATIENT TO FALL. THE CAREGIVER TRIED TO CATCH THE PATIENT USING THE KNEE, BUT WAS UNSUCCESSFUL AND ENDED UP UNDER THE PATIENT TO ABSORB THE FALL. AS A RESULT, THE PATIENT WAS NOT INJURED, BUT THE CAREGIVER SUSTAINED A STRAIN INJURY.

  Patient problems: Fall; Muscle/Tendon Damage

  MAUDE report 21707035 ↗
• InjuryFeb 10, 2025Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. THE EVENT OCCURRED DURING A PATIENT TREATMENT WHEN THE PATIENT WAS ON THE SIDE OF THE CAREVO AND THE SIDE SUPPORTS WERE IN THE MIDDLE POSITION. IT WAS REPORTED THAT THE SIDE SUPPORT OPENED, CAUSING THE PATIENT TO FALL TO THE GROUND. AS A RESULT, THE PATIENT SUSTAINED HEAD TRAUMA AND A SHOULDER FRACTURE. THIS REQUIRED HOSPITALIZATION. THE DEVICE WAS INSPECTED BY AN ARJO TECHNICIAN. EVALUATION OF THE DEVICE SHOWED VISUAL DAMAGES ON BOTH SIDE SUPPORTS. THE DEVICE PASSED FUNCTION TEST RESULTS.

  Patient problems: Bone Fracture(s); Fall; Head Injury

  MAUDE report 21341938 ↗
• InjuryFeb 10, 2025Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. THE EVENT OCCURRED DURING A PATIENT TREATMENT WHEN THE PATIENT WAS ON THE SIDE OF THE CAREVO AND THE SIDE SUPPORTS WERE IN THE MIDDLE POSITION. IT WAS REPORTED THAT THE SIDE SUPPORT OPENED, CAUSING THE PATIENT TO FALL TO THE GROUND. AS A RESULT, THE PATIENT SUSTAINED HEAD TRAUMA AND A SHOULDER FRACTURE. THIS REQUIRED HOSPITALIZATION. THE DEVICE WAS INSPECTED BY AN ARJO TECHNICIAN. EVALUATION OF THE DEVICE SHOWED VISUAL DAMAGES ON BOTH SIDE SUPPORTS. THE DEVICE PASSED FUNCTION TEST RESULTS.

  Patient problems: Bone Fracture(s); Fall; Head Injury

  MAUDE report 21341937 ↗
• MalfunctionJan 13, 2025Use of Device Problem; Use of Device Problem

  ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A CAREVO SHOWER TROLLEY. THE RESIDENT WAS TRANSFERRED FROM A BED TO THE CAREVO DEVICE USING A SLIDING SLING. DURING THE TRANSFER FROM THE BED TO THE CAREVO DEVICE, THE RESIDENT SLIPPED BETWEEN THE BED AND THE CAREVO DEVICE. THE CAREVO DEVICE SLID AWAY. ACCORDING TO THE RESIDENT AND THE CAREGIVER, THE BRAKE WAS NOT PROPERLY APPLIED. AT THE TIME, THE RESIDENT WAS ASSISTED BY 1 CARER. THE RESIDENT WAS THEN LIFTED OFF THE FLOOR USING A PASSIVE LIFT. AS A CONSEQUENCE THE RESIDENT SUSTAINED BRUISES ON FOREHEAD, LEFT HIP AND HAD PAINFUL LEFT FOOT. THE RESIDENT DID NOT GO TO HOSPITAL. SHE WAS EXAMINED BY A NURSE SPECIALIST.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 21135847 ↗
• InjuryOct 9, 2024Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. IT WAS INDICATED THAT THE SIDE SUPPORT HAD OPENED, CAUSING THE PATIENT TO FALL FROM THE DEVICE. AS A RESULT, THE PATIENT SUSTAINED AN INJURY TO THE LIPS, WHICH WERE BLEEDING. THIS REQUIRED THREE STITCHES TO BE APPLIED.

  Patient problems: Fall; Laceration(s)

  MAUDE report 20406129 ↗
• InjuryOct 9, 2024Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. IT WAS INDICATED THAT THE SIDE SUPPORT HAD OPENED, CAUSING THE PATIENT TO FALL FROM THE DEVICE. AS A RESULT, THE PATIENT SUSTAINED AN INJURY TO THE LIPS, WHICH WERE BLEEDING. THIS REQUIRED THREE STITCHES TO BE APPLIED.

  Patient problems: Fall; Laceration(s)

  MAUDE report 20406128 ↗
• MalfunctionMay 13, 2024Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. IT WAS INDICATED THAT THE SIDE SUPPORT OPENED UNINTENDED, CAUSING THE PATIENT TO FALL FROM THE CAREVO. THE PATIENT WAS CAUGHT BY THE CAREGIVER. AS A RESULT, THE PATIENT SUSTAINED SCRATCHES ON THE LEFT KNEE.

  Patient problems: Fall; Laceration(s)

  MAUDE report 19296009 ↗
• MalfunctionApr 10, 2024Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. IT WAS INDICATED THAT THE CAREGIVERS WANTED TO WASH THE RESIDENT'S BACK AND ROLLED THE RESIDENT OVER. THE SIDE SUPPORT OF THE DEVICE OPENED, CAUSING THE RESIDENT TO FALL FROM THE DEVICE. AS A RESULT, THE RESIDENT SUSTAINED A FACIAL BRUISE AND A SMALL CUT ABOVE THE RIGHT EYE. THE RESIDENT WAS TAKEN TO A LOCAL HOSPITAL AND IS NOW BACK IN THE CARE HOME.

  Patient problems: Bruise/Contusion; Laceration(s)

  MAUDE report 19076982 ↗
• InjuryJan 15, 2024Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT WHILE BATHING A PATIENT USING THE CAREVO SHOWER TROLLEY, THE CAREGIVERS PULLED THE PATIENT'S HANDS AND BODY TO THE LEFT SIDE, LEANING AGAINST THE CAREGIVER, WHEN THE SIDE SUPPORT RELEASED UNINTENTIONALLY AND THE PATIENT STARTED TO FALL ONTO THE CAREGIVER. THE CAREGIVER HELD THE PATIENT'S BODY AND BOTH THE PATIENT AND CAREGIVER FELL TO THE GROUND WITH THE SIDE SUPPORT. AS A RESULT, THE PATIENT'S HEAD HIT THE FLOOR AND BEGAN TO BLEED. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A CEREBRAL HEMORRHAGE. THE CUSTOMER WAS INTERVIEWED THE DAY AFTER THE INCIDENT, AND DURING THE INTERVIEW, INFORMATION WAS OBTAINED THAT THE PATIENT WAS CONSCIOUS AND THE HEMORRHAGE HAD STOPPED. ACCORDING TO THE CUSTOMER, THE CAREGIVER WAS ALSO INJURED - PAIN TO THE BACK AND HAND, BUT THE INJURY DID NOT REQUIRE TREATMENT.

  Patient problems: Fall; Head Injury; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18510146 ↗
• InjuryJan 15, 2024Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT WHILE BATHING A PATIENT USING THE CAREVO SHOWER TROLLEY, THE CAREGIVERS PULLED THE PATIENT'S HANDS AND BODY TO THE LEFT SIDE, LEANING AGAINST THE CAREGIVER, WHEN THE SIDE SUPPORT RELEASED UNINTENTIONALLY AND THE PATIENT STARTED TO FALL ONTO THE CAREGIVER. THE CAREGIVER HELD THE PATIENT'S BODY AND BOTH THE PATIENT AND CAREGIVER FELL TO THE GROUND WITH THE SIDE SUPPORT. AS A RESULT, THE PATIENT'S HEAD HIT THE FLOOR AND BEGAN TO BLEED. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A CEREBRAL HEMORRHAGE. THE CUSTOMER WAS INTERVIEWED THE DAY AFTER THE INCIDENT, AND DURING THE INTERVIEW, INFORMATION WAS OBTAINED THAT THE PATIENT WAS CONSCIOUS AND THE HEMORRHAGE HAD STOPPED. ACCORDING TO THE CUSTOMER, THE CAREGIVER WAS ALSO INJURED - PAIN TO THE BACK AND HAND, BUT THE INJURY DID NOT REQUIRE TREATMENT.

  Patient problems: Fall; Head Injury; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18510145 ↗
• DeathJun 27, 2023Use of Device Problem; Use of Device Problem

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF CAREVO SHOWER TROLLEY. AFTER CONTACTING THE FACILITY, IT WAS REPORTED THAT THE RESIDENT HAD FALLEN OUT OF THE DEVICE AND DIED AS A RESULT OF THE FALL. BASED ON THE INFORMATION RECEIVED, BOTH SIDE SUPPORTS OF THE CAREVO WERE OPENED TO TRANSFER THE RESIDENT TO A BED. ONE OF THE CAREGIVERS WAS AT THE HEAD OF THE CAREVO, WHILE THE SECOND CAREGIVER WAS AT THE FOOT SECTION OF THE DEVICE. ONE OF THE CAREGIVERS WENT TOWARDS THE BED TO TRANSFER THE RESIDENT. AT THIS POINT, THE RESIDENT TURNED AROUND TO WHERE THE BED WAS NOT AND FELL TO THE FLOOR.

  Patient problems: Fall

  MAUDE report 17207425 ↗
• DeathJun 27, 2023Use of Device Problem; Use of Device Problem

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF CAREVO SHOWER TROLLEY. AFTER CONTACTING THE FACILITY, IT WAS REPORTED THAT THE RESIDENT HAD FALLEN OUT OF THE DEVICE AND DIED AS A RESULT OF THE FALL. BASED ON THE INFORMATION RECEIVED, BOTH SIDE SUPPORTS OF THE CAREVO WERE OPENED TO TRANSFER THE RESIDENT TO A BED. ONE OF THE CAREGIVERS WAS AT THE HEAD OF THE CAREVO, WHILE THE SECOND CAREGIVER WAS AT THE FOOT SECTION OF THE DEVICE. ONE OF THE CAREGIVERS WENT TOWARDS THE BED TO TRANSFER THE RESIDENT. AT THIS POINT, THE RESIDENT TURNED AROUND TO WHERE THE BED WAS NOT AND FELL TO THE FLOOR.

  Patient problems: Fall

  MAUDE report 17207423 ↗
• MalfunctionOct 31, 2022Unintended System Motion; Unintended System Motion

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT A PATIENT FELL OUT OF THE DEVICE. ACCORDING TO THE INFORMATION REPORTED THE PATIENT WAS BEING BATHED BY A NURSE AND A NURSING ASSISTANT USING THE CAREVO SHOWER TROLLEY. THE PATIENT WAS A MALE WEIGHING OVER 100 KG. WHEN THEY TURNED HIM ON THE SIDE, HE WAS LEANING TOWARD THE RIGHT SIDE SUPPORT WHICH GOT RELEASED AND PATIENT FELL DOWN ON THE FLOOR. THERE WAS THE NURSING ASSISTANT STANDING ON THE SIDE AND THE PATIENT SLID DOWN ON HIS LEGS. THE PATIENT WAS CAUGHT BY THE LEGS OF THE ASSISTANT. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Fall

  MAUDE report 15697802 ↗
• InjuryMar 25, 2020Unintended System Motion; Unintended System Motion

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT WHEN THE CAREGIVER TURNED THE PATIENT OVER, THE SIDE SUPPORT OPENED AND THE PATIENT FELL TO THE GROUND. THE PATIENT WAS INJURED AND TAKEN TO THE EMERGENCY ROOM. ACCORDING TO THE RECEIVED INFORMATION THE PATIENT SUSTAINED THE FOLLOWING INJURIES - BROKEN FEMUR, SWOLLEN NOSE, SWOLLEN FOREHEAD. THE PATIENT WAS HOSPITALIZED.

  Patient problems: Bone Fracture(s); Swelling

  MAUDE report 9876638 ↗
• InjuryMar 25, 2020Unintended System Motion; Unintended System Motion

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT WHEN THE CAREGIVER TURNED THE PATIENT OVER, THE SIDE SUPPORT OPENED AND THE PATIENT FELL TO THE GROUND. THE PATIENT WAS INJURED AND TAKEN TO THE EMERGENCY ROOM. ACCORDING TO THE RECEIVED INFORMATION THE PATIENT SUSTAINED THE FOLLOWING INJURIES - BROKEN FEMUR, SWOLLEN NOSE, SWOLLEN FOREHEAD. THE PATIENT WAS HOSPITALIZED.

  Patient problems: Bone Fracture(s); Swelling

  MAUDE report 9876626 ↗
• InjuryOct 28, 2019Device Fell; Device Fell

  ARJO WAS NOTIFIED ABOUT AN INCIDENT WITH INVOLVEMENT OF CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT THE RESIDENT WAS BEING SHOWERED WHEN CARER ROLLED HIM TOWARD HIMSELF, THE RIGHT SIDE SUPPORT OPENED UNINTENDED AND THE RESIDENT FELL ONTO THE FLOOR. THE PATIENT SUSTAINED A BRUISING TO RIGHT SIDE OF FOREHEAD, BRUISING TO ELBOW, TOES AND RED MARK TO BACK OF RIGHT THIGH.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 9243501 ↗
• MalfunctionJun 11, 2019Device Fell; Device Fell

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF CAREVO SHOWER TROLLEY. IT WAS REPORTED THAT DURING SHOWER, WHEN THE PATIENT WAS ON HER SIDE AND LEANING ON THE SIDE SUPPORT (BECAUSE THE CAREGIVER WAS WASHING HER BACK), THE SIDE SUPPORT OPENED AND THE PATIENT FELL. NO INFORMATION REGARDING AN INJURY OCCURRENCE HAS BEEN MADE AVAILABLE TO DATE.

  Patient problems: Fall; Head Injury; Hematoma

  MAUDE report 8686055 ↗