Tobii Dynavox TD Navio MaxiRecalls & reported problems
Tobii Dynavox LLC · TD Navio Mini, Model: TDNL1, is a Speech Generating Device (aka AAC Device), Powered Communication System. It is a large, portable iOS-based device. The unit comes with its communication software in order meet the needs of individuals who cannot speak. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340074602070), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Appropriate Device Problem Term/Code Not Available
NAVIO MIDI AND NAVIO MAXI ARE SPEECH-GENERATING AAC MEDICAL DEVICES POWERED BY AN INTERNAL LITHIUM-ION POUCH BATTERY. DURING REPAIR INTAKE ON A DEVICE RETURNED ON FEBRUARY 10TH FOR UNRELATED FUNCTIONAL ISSUES, FRACTURE OF INTERNAL BATTERY MOUNTING TABS WAS IDENTIFIED WITH EVIDENCE OF PRIOR DROP OR IMPACT DAMAGE. THE FRACTURED INTERNAL HOUSING CONTACTED AND COMPROMISED THE PRISMATIC LITHIUM-ION BATTERY CASING, LEADING TO AN INTERNAL SHORT CIRCUIT AND LOCALIZED THERMAL EVENT WITH INTERNAL HEATING AND BATTERY GAS VENTING; NO THERMAL EFFECTS EXTENDED BEYOND INTERNAL COMPONENTS. THE EXTERNAL ENCLOSURE REMAINED INTACT, AND NO SUSTAINED FIRE OR EXPLOSION OCCURRED. PREVIOUSLY FIVE CASES INVOLVED FRACTURED MOUNTING TABS ONLY, WITHOUT BATTERY POUCH DAMAGE, INTERNAL SHORT, THERMAL EFFECTS, HEAT, SMOKE, OR USER EXPOSURE. THOSE CASES WERE INITIALLY ASSESSED AS NON-REPORTABLE QUALITY FINDINGS BECAUSE NO BATTERY COMPROMISE, NO HAZARDOUS SITUATION, AND NO INJURY OR POTENTIAL FOR INJURY WERE IDENTIFIED AT THE TIME. THE SIXTH CASE INVOLVING LOCALIZED THERMAL RUNAWAY TRIGGERED ESCALATION AND REPORTABILITY ASSESSMENT. NO HEALTH EFFECTS WERE OBSERVED IN ANY CASE. NO INJURIES, CLINICAL SIGNS, OR SYMPTOM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24797451 ↗
Other System, Communication, Powered devices
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- NaviCare® Nurse Call Systems 3.9Hill-Rom, Inc. · System, communication, powered2 recalls2 deaths87 reports
- NaviCare® Nurse Call Systems 3.6Hill-Rom, Inc. · System, communication, powered1 recall12 reports
- NaviCare® Nurse Call Systems 3.7Hill-Rom, Inc. · System, communication, powered1 recall0 reports
- Tobii Dynavox TD I-110Tobii Dynavox LLC · System, Communication, Powered1 recall0 reports
- Voalte Nurse Call 4.1Hill-Rom, Inc. · System, communication, powered14 reports
- GEN4 DIRECT ACCESS 4C370U-P10424CCurbell Medical Products, Inc. · System, Communication, Powered3 reports
- GEN4 PLUS, RESPONDER 5, ENHANCED 5C410U-10134003ACurbell Medical Products, Inc. · System, Communication, Powered3 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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