DRIVEMEDICAL RTL12606Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383525891), received between Aug 12, 2021 and Jan 23, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2025Mechanical Problem; Mechanical Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH SEAT BY AN OCCUPATIONAL THERAPIST, WHO STATED THAT THE PLASTIC PART OF THE SEAT THAT HOLDS THE REAR LEFT LEG BROKE OFF, CAUSING THE END USER TO FALL. THE END USER, WHO HAD SUSTAINED A CONCUSSION TEN MONTHS PRIOR TO THE INCIDENT, REPORTEDLY BEGAN DEMONSTRATING SYMPTOMS AGAIN AND SOUGHT MEDICAL ATTENTION. 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

  MAUDE report 21219042 ↗
• InjuryJul 18, 2022Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE RECEIVED A REPORT REGARDING AN INCIDENT INVOLVING A SHOWER CHAIR WITH FOLDING BACK FROM AN END USER, WHO STATED THAT THE CHAIR "FELL APART WHILE SHE WAS IN THE SHOWER" BECAUSE IT "SPLIT DOWN THE SIDE." THE END USER REPORTED HURTING HER BACK AND HITTING HER HEAD. AN AMBULANCE ARRIVED ON SCENE AND CHECKED THE END USER, BUT SHE DID NOT GO TO THE HOSPITAL. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT TO EVALUATE IT. DRIVE WILL UPDATE THIS FILING IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Head Injury

  MAUDE report 15043690 ↗
• InjuryAug 12, 2021Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A SHOWER CHAIR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW-UP WILL BE FILED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE BATH BENCH BROKE WHILE IN USE IN THE SHOWER. THE USER FELL. SHE REINJURED HER FEMORAL HEAD WHICH HAD ALREADY UNDERGONE SURGERY AND IS CURRENTLY UNDER TREATMENT. THE FRACTURE WAS SO CLOSE TO THE KNEE THAT IT WAS DAMAGED AS WELL. TREE IS A POTENTIAL OF SURGERY ON THE KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12316876 ↗