Digital Therapist 2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05065013876009), received between Apr 24, 2026 and Aug 13, 2026 — classified as 3 injuries.

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.

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.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  The member fell during a Digital Therapist session while performing a right leg hamstring stretch. The member reported injury to the right hip and leg, with pain and difficulty bearing weight on the affected leg. The member subsequently sought medical evaluation and was diagnosed with a fractured right hip and torn thigh muscle. The injuries required a full right hip replacement and surgical repair of the torn thigh muscle.

  Patient problems: Fall; Hip Fracture; Muscle/Tendon Damage

  MAUDE report 50232580 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE MEMBER EXPRESSED CONCERN ABOUT A POSSIBLE RIB FRACTURE TO THE ASSIGNED PHYSICAL THERAPIST (PT) AFTER LOSING BALANCE DURING AN EXERCISE SESSION AND LANDING ON THE CORNER OF A TABLE. AT THE TIME OF THE REPORT, THE MEMBER HAD COMPLETED TWO THERAPY SESSIONS WITH THE DIGITAL THERAPIST (B)(6) 2026). THE MEMBER REPORTED ELEVATED PAIN LEVELS DURING BOTH SESSIONS. THE ASSIGNED PHYSICAL THERAPIST FOLLOWED UP AFTER EACH SESSION TO PROVIDE GUIDANCE AND ADJUST THE THERAPY PROGRAM BASED ON REPORTED SYMPTOMS. PRIOR TO STARTING THE PROGRAM, THE PHYSICAL THERAPIST ALSO REINFORCED THE RECOMMENDATION TO HOLD ONTO A STABLE OBJECT DURING STANDING EXERCISES AS A BALANCE-SUPPORT MEASURE. FOLLOWING THE REPORT OF THE INCIDENT, THE PHYSICAL THERAPIST REQUESTED ADDITIONAL DETAILS REGARDING THE EVENT AND INQUIRED WHETHER MEDICAL EVALUATION HAD BEEN SOUGHT. NO FURTHER INFORMATION OR MEDICAL CONFIRMATION OF RIB FRACTURE HAS BEEN RECEIVED FROM THE MEMBER DESPITE MULTIPLE FOLLOW-UP ATTEMPTS VIA MESSAGING AND PHONE CALLS THROUGH (B)(6) 2026. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT INVOLVED LOSS OF BALANCE DURING EXERCISE PERFORMANCE. NO DEVICE MALFUNCTION OR TECHNICAL ISSUE WAS I

  Patient problems: Bone Fracture(s)

  MAUDE report 25121475 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  THE MEMBER REPORTED THAT AFTER INITIATING USE OF THE DIGITAL THERAPIST PROGRAM ON (B)(6) 2026, THEY EXPERIENCED SWELLING IN THE RIGHT FOOT WITHIN THE FIRST FEW DAYS OF PERFORMING THE PRESCRIBED EXERCISES. THE MEMBER COMPLETED A TOTAL OF 13 SESSIONS, WITH THE LAST SESSION PERFORMED ON (B)(6) 2026. THE MEMBER REPORTED RECEIVING AN X-RAY EVALUATION FROM ON (B)(6) INDICATING A STRESS FRACTURE OF THE RIGHT FOOT DESCRIBED AS BEING IN A HEALING PHASE. THE MEMBER ATTRIBUTED THE FRACTURE TO THE EXERCISES PERFORMED DURING THE INITIAL PHASE OF THE PROGRAM. THEY STATED THAT SWELLING BEGAN AFTER STARTING THE PROGRAM AND PERSISTED. THE MEMBER ALSO REPORTED THAT THEY WERE UNABLE TO PERFORM SOME MOVEMENTS DUE TO PRE-EXISTING LIMITATIONS. THE MEMBER INDICATED THAT THEY ENGAGE IN ADDITIONAL REGULAR PHYSICAL ACTIVITY, INCLUDING DAILY POOL-BASED EXERCISE AND WEEKLY SESSIONS WITH A GYM TRAINER. THE PHYSICAL THERAPIST ATTEMPTED TO FOLLOW UP WITH THE MEMBER TO ASSESS SYMPTOMS AND SCHEDULE A CALL; HOWEVER, COMMUNICATION WAS INCONSISTENT AND MULTIPLE OUTREACH ATTEMPTS WERE NOT ANSWERED. FOLLOWING THE REPORT OF THE STRESS FRACTURE, THE THERAPY PROGRAM WAS PLACED ON HOLD.

  Patient problems: Bone Fracture(s)

  MAUDE report 24976697 ↗