Renú Voice 08-015-04-V04Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00856509002294), received between Oct 6, 2017 and Jul 22, 2020 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL OPERATING ROOM (OR) INJECTION OF 0.7ML OF RENÚ VOICE INTO THE POSTEROLATERAL ASPECT OF THE LEFT VOCAL FOLD ON (B)(6) 2019 FOR LEFT TRUE VOCAL FOLD PARALYSIS AND DYSPHONIA. NO PROCEDURAL COMPLICATIONS WERE NOTED AND THE PATIENT'S VOICE WAS REPORTED TO BE "AUDIBLY LOUDER AND STRONGER" POST-INJECTION. SEVERE SWELLING (EDEMA OF THE LARYNX) WITH DYSPNEA WAS NOTED ON (B)(6) 2019 AND THE PATIENT TREATED WITH 8MG OF INTRAVENOUS STEROIDS (DEXAMETHASONE (DECADRON)) IN THE HOSPITAL FOR TWO (2) DAYS. THE PATIENT WAS DISCHARGED (B)(6) 2019. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2019 THE SWELLING WAS NOTED TO IMPROVE WITH THE STEROID TREATMENT. ((B)(4)).

  Patient problems: Dyspnea; Edema

  MAUDE report 10312068 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL OPERATING ROOM (OR) TRANSORAL INJECTION OF 1.0ML OF RENÚ VOICE INTO THE POSTEROLATERAL LEFT VOCAL FOLD ON (B)(6) 2018 FOR LEFT TRUE VOCAL FOLD PARALYSIS, DYSPHONIA, AND DYSPHAGIA. NO PROCEDURAL COMPLICATIONS WERE NOTED BUT SEVERE COUGHING AFTER EXTUBATION WAS REPORTED, WHICH RESOLVED. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2018, IMMOBILITY OF THE VOCAL FOLD WAS NOTED AND THYROID CANCER DETERMINED TO BE THE MOST LIKELY CAUSE. HYPOMOBILITY OF THE RIGHT TRUE VOCAL FOLD AS WELL AS STIFFNESS IN THE VOCAL FOLDS WERE ALSO NOTED. THE PHYSICIAN WAS UNSURE IF THE IMPLANT PARTIALLY RESORBED PREMATURELY OR MAY BE CAUSING THE VOCAL FOLD STIFFNESS. (REF. (B)(4)).

  Patient problems: Muscular Rigidity

  MAUDE report 10312036 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL OPERATING ROOM (OR) PERCUTANEOUS INJECTION OF RENÚ VOICE INTO BOTH THE LEFT AND RIGHT VOCAL FOLDS ON (B)(6) 2018 FOR RIGHT VOCAL FOLD PARALYSIS, DYSPHAGIA, AND ESOPHAGEAL STENOSIS. ONE (1) ML OF PRODUCT WAS INJECTED INTO THE RIGHT VOCAL FOLD AND 0.2ML INJECTED INTO THE LEFT VOCAL FOLD. NO PROCEDURAL COMPLICATIONS WERE NOTED. THE PHYSICIAN REPORTED THE PATIENT WAS UNABLE TO SPEAK FOLLOWING THE SURGERY. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2018, IT WAS NOTED THAT THE INABILITY TO SPEAK HAS SINCE IMPROVED BUT THE DYSPHAGIA AND DYSPHONIA HAVE WORSENED. ((B)(4)).

  Patient problems: Dysphagia/ Odynophagia; Injury

  MAUDE report 10312017 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL OPERATING ROOM (OR) TRANSORAL INJECTION OF RENÚ VOICE INTO BOTH THE LEFT AND RIGHT VOCAL FOLDS ON (B)(6) 2019 FOR RIGHT VOCAL FOLD PARALYSIS, PROFOUND DYSPHAGIA, AND LEFT VOCAL FOLD ATROPHY USING A RENÚ TRANSORAL NEEDLE. 0.3 CC OF PRODUCT WAS INJECTED INTO THE RIGHT VOCAL FOLD AND 0.5 CC INJECTED INTO THE LEFT VOCAL FOLD. NO PROCEDURAL COMPLICATIONS WERE NOTED. A SECOND TRANSORAL INJECTION IN THE OR WAS NOTED AS PERFORMED (B)(6) 2019 USING PROLARYN GEL AND RENÚ VOICE INJECTED INTO THE POSTERIOR PHARYNGEAL WALL. THE SECOND INJECTION OCCURRED BECAUSE THE LEFT VOCAL FOLD APPEARED UN-AUGMENTED. DURING A FOLLOW-UP APPOINTMENT POST THIS SECOND REPORTED INJECTION ON (B)(6) 2020 THE PHYSICIAN REPORTED THE PATIENT'S VOICE WAS NOTED AS BEING HIGH-PITCHED AND DIFFICULT TO PROJECT. THE PATIENT REPORTED IT IS EFFORTFUL TO SPEAK AND HIS VOICE FATIGUES/GIVES OUT THE MORE HE TALKS. NO PAIN OR DISCOMFORT WERE REPORTED. THE PATIENT HAS A HISTORY OF TONSIL CANCER. ((B)(4)).

  Patient problems: Injury

  MAUDE report 10311995 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL AN OPERATING ROOM (OR) TRANSORAL INJECTION OF RENÚ VOICE INTO BOTH THE LEFT AND RIGHT VOCAL FOLDS ON (B)(6) 2019 FOR LEFT VOCAL FOLD PARALYSIS AND RIGHT VOCAL FOLD ATROPHY USING A RENÚ TRANSORAL NEEDLE. 0.35 ML OF PRODUCT WAS INJECTED INTO EACH VOCAL FOLD. NO PROCEDURAL COMPLICATIONS WERE NOTED. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2019 THE PHYSICIAN REPORTED THE IMMOBILITY OF THE LEFT VOCAL FOLD REMAINED UNCHANGED AND NO IMPROVEMENT IN THE ABILITY TO INCREASE VOLUME, BUT THE DYSPHONIA AND THE VOICE QUALITY/PHONATION IMPROVED. THE PATIENT REPORTED HER VOICE WAS "DIFFERENT", ROUGHNESS, NO CHANGE IN VOLUME, AND IT WAS HARDER/MORE EFFORTFUL TO SPEAK. (REF. (B)(4)).

  Patient problems: Injury

  MAUDE report 10311922 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL OR TRANSORAL INJECTION OF RENÚ VOICE AT THE VOCAL PROCESS IN THE PARAGLOTTIC SPACE OF THE BOTH VOCAL FOLDS FOR MUSCLE TENSION DYSPHONIA, VOCAL CORD ATROPHY, AND A LARYNGEAL MASS USING A RENÚ TRANSORAL NEEDLE. NO PROCEDURAL COMPLICATIONS WERE NOTED. DURING A FOLLOW-UP APPOINTMENT TWENTY-EIGHT (28) DAYS POST-INJECTION, VOICE QUALITY WAS NOTED AS "VERY DYSPHONIC, EFFORTFUL, AND CANNOT PROJECT, ROUGH" BY THE PHYSICIAN. THE PHYSICIAN ALSO REPORTED "BOTH THE RIGHT AND LEFT TRUE VOCAL CORDS ARE FULL IN ABDUCTION/ADDUCTION; WITH SMOOTH VOCAL FOLD EDGE AND NO ATROPHY/BOWING." THE PATIENT REPORTED SHE FEELS LIKE SHE "IS STRAINING TO TALK AND DOES NOT THINK THE INJECTION HELPED." THE PHYSICIAN ALSO NOTED NO IMPROVEMENT IN QUALITY OF VOICE OR ABILITY TO INCREASE VOICE VOLUME. PATIENT'S CURRENT STATUS IS VOICE REMAINS DYSPHONIC. PATIENT DID NOT EXPLICITLY STATE DYSPHONIA/EFFORTFUL/ROUGH VOICE WORSENED AFTER INJECTION. THE PATIENT ALSO HAD THYROARYTENOID BOTOX INJECTIONS BOTH BEFORE AND AFTER THE RENÚ INJECTION. (REF. (B)(4)).

  Patient problems: Injury

  MAUDE report 10308269 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL IN OFFICE TRANSORAL INJECTION OF RENÚ VOICE LATERAL TO THE VOCAL PROCESS AND DEEP INTO THE THYROARYTENOID MUSCLE OF THE RIGHT VOCAL FOLD FOR DYSPHAGIA AND DYSPHONIA USING A RENÚ TRANSORAL NEEDLE. NO PROCEDURAL COMPLICATIONS OR SUPERFICIAL INJECTION WERE NOTED. DURING A FOLLOW-UP APPOINTMENT FORTY-TWO (42) DAYS POST-INJECTION, VOICE QUALITY WAS NOTED AS "VERY DYSPHONIC." THE RIGHT VOCAL FOLD WAS REPORTED AS "PLUMPED", "STIFF", AND "IMMOBILE" WITH NO SUPERFICIAL INJECTION NOTED. THE LEFT VOCAL FOLD IS REPORTED AS HAVING FULL ABDUCTION/ADDUCTION WITH SMOOTH VOCAL FOLD EDGE AND NO ATROPHY/BOWING. THE PATIENT REPORTED THE "INJECTION DID NOT HELP HIM AND POSSIBLY MADE HIS VOICE WORSE." THE PHYSICIAN ALSO REPORTED VOICE QUALITY AND ABILITY TO INCREASE VOICE VOLUME HAVE DECREASED. THE PATIENT'S RIGHT VOCAL FOLD IMMOBILITY WAS REPORTED TO NOT BE A RESULT OF THE INJECTION BUT ALSO HAS NOT RESOLVED. THE PATIENT'S RIGHT VOCAL FOLD WAS PREVIOUSLY INJECTED WITH VOICE GEL. THE PATIENT'S VOICE HAS NOT IMPROVED AND CONTINUED TO DETERIORATE. THE PATIENT'S VOICE IS CURRENTLY VERY DYSPHONIC. ((B)(4)).

  Patient problems: Injury

  MAUDE report 10308260 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL OR TRANSORAL INJECTION OF RENÚ VOICE LATERAL TO THE VOCAL LIGAMENT IN THE PARAGLOTTIC SPACE AND A SMALL INJECTION INTO THE MID FOLD FOR RIGHT VOCAL FOLD PARESIS AND DYSPHONIA USING A RENÚ TRANSORAL NEEDLE. NO PROCEDURAL COMPLICATIONS OR SUPERFICIAL INJECTION WERE NOTED. THE PHYSICIAN REPORTED "OVERCORRECTION WAS MINIMAL." DURING A FOLLOW-UP APPOINTMENT THIRTY-NINE (39) DAYS POST-INJECTION, VOICE QUALITY WAS REPORTED BY THE PHYSICIAN AS "SLIGHTLY DYSPHONIC." THE PHYSICIAN NOTED BOTH VOCAL FOLDS HAVE SMOOTH EDGES WITH NO ATROPHY/BOWING, THE LEFT TRUE VOCAL FOLD HAS FULL RANGE OF MOTION WHILE THE RIGHT HAS PARTIAL ABDUCTION/ADDUCTION. THE RIGHT SIDED PARTIAL ABDUCTION/ADDUCTION WAS PRESENT PRIOR TO THE INJECTION PROCEDURE. THE PATIENT REPORTED HE DID NOT NOTICE ANY IMPROVEMENT IN HIS VOICE OR SWALLOWING AND IT IS MORE DIFFICULT TO PROJECT HIS VOICE SINCE THE SURGERY BUT DOES NOT REPORT PAIN. THE PHYSICIAN REPORTED VOICE QUALITY, ABILITY TO INCREASE VOICE VOLUME, AND SWALLOWING WERE NOT IMPROVED BY THE INJECTION PROCEDURE. THE PATIENT WAS SUBSEQUENTLY TREATED WITH A "GENERIC VOICE GEL" AFTER THE RENÚ INJECTION (NO DATE PROVIDED). THE PATIENT'S VOICE

  Patient problems: Injury

  MAUDE report 10308230 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN UNEVENTFUL IN OFFICE PERCUTANEOUS INJECTION OF RENÚ VOICE INTO THE LEFT VOCAL FOLD LATERAL TO THE THYROARYTENOID MUSCLE AT THE LEVEL OF THE VOCAL PROCESS FOR LEFT VOCAL FOLD PARALYSIS, DYSPHAGIA, AND DYSPHONIA. NO PROCEDURAL COMPLICATIONS OR SUPERFICIAL INJECTION WERE NOTED. DURING A FOLLOW-UP APPOINTMENT THIRTY-ONE (31) DAYS POST-INJECTION, VOICE QUALITY WAS NOTED AS "MODERATELY DYSPHONIC", THE LEFT TRUE VOCAL FOLD IS IMMOBILE WITH MODERATE ATROPHY/BOWING AND THE RIGHT TRUE VOCAL FOLD HAS FULL ABDUCTION/ADDUCTION WITH MILD ATROPHY/BOWING. THE PATIENT REPORTED HIS VOICE WAS GOOD FOR TWO WEEKS AND THEN DETERIORATED. THE PATIENT STATED IT WAS HARD TO SPEAK AND HIS VOICE WAS VERY BREATHY AND "AIRY." THE PHYSICIAN REPORTED VOICE QUALITY AND THE ABILITY TO INCREASE VOICE VOLUME WERE NOT IMPROVED BY THE INJECTION PROCEDURE AND THE VOICE IS NOW NEARLY BACK TO BASELINE AND HYPOPHONIC. LEFT SIDED VOCAL FOLD IMMOBILITY AND ATROPHY/BOWING WAS PRESENT BEFORE INJECTION WITH RENÚ BUT RIGHT SIDED VOCAL FOLD ATROPHY/BOWING DEVELOPED AFTER INJECTION. THE PATIENT HAD A MEDIALIZATION THYROPLASTY PERFORMED AFTER THE RENÚ INJECTION (NO INJECTION DATE PROVIDED). THE PATIENT'S VO

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10308191 ↗
• InjurySep 17, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2017, THE PATIENT UNDERWENT AN UNEVENTFUL TRANSORAL INJECTION OF RENÚ VOICE FOR PRESBYLARYNGIS, BILATERAL THINNING. THE PROCEDURE WAS REPORTED TO HAVE OCCURRED IN AN OPERATING ROOM UNDER ANESTHESIA USING STANDARD EQUIPMENT, INCLUDING A STORZ TELESCOPE 5MM, ZERO DEGREE, CAMERA, AND REDO LARYNGOSCOPE. THE RENÚ VOICE WAS INJECTED TRANSORALLY USING A RENÚ TRANSORAL NEEDLE. IT WAS REPORTED THAT BOTH THE RENÚ VOICE AND THE RENÚ TRANSORAL NEEDLE DEVICE PACKAGING WERE INTACT AND UNDAMAGED WHEN OPENED BY THE PHYSICIAN. NO NOTED DIFFICULTIES WERE REPORTED TO HAVE BEEN EXPERIENCED DURING THE PROCEDURE. IT WAS NOTED THAT FOLLOWING THE PROCEDURE "THE PATIENT HAD NORMAL VOCAL CORD STRUCTURES AND APPROPRIATE BILATERAL AUGMENTATION." ON (B)(6) 2017, ONE (1) DAY POST OPERATION, IT WAS REPORTED THAT THE PATIENT CALLED THE FACILITY REPORTING SEVERE POST OPERATIVE THROAT PAIN. THE PATIENT WAS INSTRUCTED BY THE FACILITY TO COME IN FOR EVALUATION. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, WAS EVALUATED AND THEN DISCHARGED TO HOME, WITH A PLAN TO FOLLOW UP WITH HER PHYSICIAN IN THE CLINIC. IT WAS REPORTED THAT THE PATIENT WAS SEEN BY HER PHYSICIAN IN THE CLINIC SIX

  Patient problems: Discomfort; Inflammation; Necrosis

  MAUDE report 7880521 ↗
• InjurySep 17, 2018Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN THE CLINIC ON (B)(6) 2018, HE HAD BEEN EXPERIENCING THREE (3) TO FOUR (4) DAYS OF BREATHY DYSPHONIA AND ASPIRATION SYMPTOMS, AS WELL AS DYSPHAGIA WITH SOLIDS, HOARSENESS, AND DRY THROAT. A DIAGNOSTIC LARYNGOSCOPY AND CT SCAN WERE BOTH PERFORMED ON (B)(6) 2018. THE DIAGNOSTIC LARYNGOSCOPY WAS REPORTED TO SHOW IDIOPATHIC LEFT VOCAL CORD PARALYSIS AND THE CT SCAN SHOWED NO ABNORMALITIES OF THE LARYNX, PHARYNX OR NECK MASSES. ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNEVENTFUL TRANSORAL INJECTION OF RENÚ VOICE FOR IDIOPATHIC LEFT VOCAL CORD PARALYSIS. THE PROCEDURE WAS REPORTED TO HAVE OCCURRED IN AN OPERATING ROOM UNDER ANESTHESIA USING STANDARD EQUIPMENT, INCLUDING A STORZ TELESCOPE 5MM, ZERO DEGREE, CAMERA, AND DEDO LARYNGOSCOPE. THE DEVICE PACKAGING WAS INTACT AND UNDAMAGED WHEN OPENED BY THE PHYSICIAN. THE RENÚ VOICE WAS INJECTED VIA A RENÚ TRANSORAL NEEDLE AND NO NOTED DIFFICULTIES WERE REPORTED TO HAVE BEEN EXPERIENCED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PATIENT'S INITIAL POST-OPERATIVE VISIT ON (B)(6) 2018 A DIAGNOSTIC LARYNGOSCOPY WAS PERFORMED. NO ABNORMALITIES WERE REPORTED. ON (B)(6) 2018 THE PATIENT WAS R

  Patient problems: Inflammation

  MAUDE report 7880507 ↗
• MalfunctionOct 6, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING A RENU VOICE PROCEDURE, THE PHYSICIAN PERFORMED AN INITIAL INJECTION OF THE RENU VOICE MATERIAL INTO THE PATIENT'S VOCAL FOLD WITHOUT ANY REPORTED ISSUE. IT WAS REPORTED BY THE PHYSICIAN'S NURSE MANAGER THAT THE PHYSICIAN THEN ATTEMPTED TO INJECT ADDITIONAL MATERIAL FROM THIS SAME SYRINGE, AND THE SYRINGE "CRACKED." IT WAS ALSO REPORTED THAT THE SYRINGE DID NOT THEN CONTAIN ENOUGH MATERIAL TO COMPLETE THE PATIENT'S PROCEDURE. SINCE THE PHYSICIAN'S OFFICE DID NOT HAVE AN ADDITIONAL RENU VOICE DEVICES AVAILABLE FOR USE DURING THE PATIENT'S PROCEDURE, THE NURSE MANAGER "BELIEVES" THAT THE PATIENT WAS OFFERED THE OPPORTUNITY TO CONTINUE AND COMPLETE THE PROCEDURE AT THE HOSPITAL WHERE ADDITIONAL RENU VOICE PRODUCTS WERE AVAILABLE FOR USE, HOWEVER THE PATIENT DECLINED TO COMPLETE THE PROCEDURE AT THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 6925638 ↗