Renú Transoral Needle 12-000-00-ND1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00856509002669), received between Sep 17, 2018 and Nov 26, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2019Fracture; Device Damaged Prior to Use; Insufficient Device Problem Information; Fracture; Device Damaged Prior to Use; Insufficient Device Problem Information

  COMPLAINANT REPORTED THE RENÚ TRANSORAL NEEDLE DEVICE (LOT Q912-00031) WAS BROKEN WHEN TAKEN OUT OF THE BOX. (REF. (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377700 ↗
• MalfunctionNov 6, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE FACILITY REPORTED THAT THE DOCTOR WAS PERFORMING A VOCAL FOLD INJECTION WHEN THE TIP OF THE NEEDLE BROKE OFF AND WAS SWALLOWED BY THE PATIENT. THE SAME DAY AS THE REPORTED EVENT, THE PATIENT UNDERWENT A CT OF THE ABDOMEN/PELVIS WHICH REVEALED A 2.8 CM LINEAR RADIOPAQUE FOREIGN BODY LOCATED WITHIN THE LUMEN OF THE MID ILEUM, WITHOUT EVIDENCE OF PERFORATION OR PENETRATION OF THE BOWEL. TWO DAYS LATER, A SUPINE ABDOMINAL X-RAY REVEALED THE LINEAR METALLIC FOREIGN BODY OVERLYING THE RIGHT PARASAGITTAL PELVIS, AND AS SEEN ON THE CURRENT LIMITED FIELD OF VIEW ABDOMINAL X-RAY, THE SAME METALLIC FOREIGN BODY IS NO LONGER VISUALIZED, PRESUMABLY HAVING BEEN EVACUATED SPONTANEOUSLY. THE FACILITY REPORTED THERE IS NO EVIDENCE TO SUGGEST BOWEL PERFORATION AS NO FREE AIR OR EXTRAPERITONEAL GAS COLLECTION WERE IDENTIFIED. PATIENT WAS SAFELY DISCHARGED A FEW DAYS LATER IN GOOD CONDITION. (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9287127 ↗
• MalfunctionOct 4, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PHYSICIAN REPORTED THAT DURING A INJECTION PROCEDURE WITH RENÚ VOICE, THE TIP OF THE RENÚ TRANSORAL NEEDLE BROKE OFF INTO A PATIENTS MOUTH/THROAT AREA. THE PHYSICIAN WAS ABLE TO RETRIEVE THE NEEDLE TIP AND NO PATIENT INJURY OCCURRED. (REF. (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9159322 ↗
• MalfunctionOct 4, 2019Detachment of Device or Device Component

  DOCTOR WAS PERFORMING A VOCAL FOLD INJECTION WHEN THE TIP OF THE NEEDLE BROKE OFF AND THE PATIENT SWALLOWED. LATER THAT DAY, A CT OF THE ABDOMEN/PELVIS REVEALED 2.8 CM LINEAR RADIOPAQUE FOREIGN BODY LOCATED WITHIN THE LUMEN OF THE MID ILEUM WITHOUT EVIDENCE OF PERFORATION OR PENETRATION OF THE BOWEL. SUPINE ABDOMINAL X-RAY TWO DAYS LATER REVEALED THE LINEAR METALLIC FOREIGN BODY OVERLYING THE RIGHT PARASAGITTAL PELVIS, AND AS SEEN ON THE CURRENT LIMITED FIELD-OF-VIEW ABDOMINAL X-RAY, THE SAME METALLIC FOREIGN BODY IS NO LONGER VISUALIZED, PRESUMABLY HAVING BEEN IN THE RECTUM AND EVACUATED SPONTANEOUSLY. NO EVIDENCE TO SUGGEST BOWEL PERFORATION, I.E. EITHER FREE AIR OR EXTRAPERITONEAL GAS COLLECTION. PATIENT SAFELY DISCHARGED A FEW DAYS LATER IN GOOD CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9155816 ↗
• 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 5 MM, ZERO DEGREE, CAMERA, AND DEDO 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 SI

  Patient problems: Discomfort; Inflammation; Necrosis

  MAUDE report 7880515 ↗