Provox Vega 22.5Fr 6mm 8283Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791010873), received between Apr 16, 2019 and Apr 23, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR CLAIMED THAT THE VP GOT DISLODGED INTO FOOD PATH SIDE DURING THE PROCEDURE WHILE PULLING THE LOADING TUBE OUT OF THE PUNCTURE. THE SAFETY STRAP DID NOT FUNCTION TO HOOK THE VP TO THE INSERTION PIN. THE USER HAD A PROCEDURE WITH ENDOSCOPY TO TAKE THE VP OUT OF THE FOOD PATH. ADDITIONAL INFORMATION: DID THEY CHECK THE SAFETY STRAP THAT IT WAS CORRECTLY ATTACHED? ANSWER: YES, THE DOCTOR CONFIRMED IT BEFORE PROCEDURE. DID THEY NEED TO ASSEMBLY AND RELOAD THE PROVOX INSERTION SYSTEM? ANSWER: NO, THEY DID NOT. IT WAS NOT POSSIBLE TO DO IT ACTUALLY. THE VP WAS SLIDING DOWN INTO THE FOOD PATH FOR THE FIRST ATTEMPT. DID THEY PERFORM AN OVERSHOOTING? ANSWER: NO, THEY DID NOT. THEY PERFORM THE NORMAL REPLACEMENT. IS IT POSSIBLE TO DESCRIBE WHAT HAPPENED DURING THE ENDOSCOPY? ANSWER: IT WAS PERFORMED JUST FOR CHECKING AND COLLECTING THE DISLODGED VP. WE HAVE SENT THE VP TO YOU BY COLLECTING THIS PROCEDURE. HOW IS THE PATIENT TODAY? ANSWER: THE PATIENT WAS FINE, INDWELLED A NEW ONE RIGHT AFTER THE INCIDENT. NO HARM AND ALSO NO PROBLEM ON VOICING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21893402 ↗
• InjuryApr 16, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THIS IS A SUMMARY OF THE INFORMATION THAT WAS RECEIVED FROM THE REPORTING SLP: PATIENT CHART NOTES NOTE DIFFICULTY WITH THE VOICING IN THE MONTHS PRIOR TO THIS EVENT, WHICH WAS PREVIOUSLY ALWAYS RESOLVED BY BRUSHING. PATIENT HAS A NARROW ESOPHAGUS, AND REPORTED NEED TO FORCE HIS VOICE. HE ALSO WEARS A TRACH DUE TO STOMA STENOSIS. PATIENT PRESENTED WITH CHANGES IN VOICING ABILITY WHICH PROGRESSED TO FEVERS AND ULTIMATELY WAS FOUND TO HAVE BACK OF TEP ERODED INTO A VERTEBRAL BODY. IT WAS EMBEDDED IN A FISTULA IN POSTERIOR WALL OF ESOPHAGUS. DOCTOR REMOVED PROSTHESIS AND PLACED ESOPHAGEAL STENT TO PROTECT THE AREA.

  Patient problems: Fistula; Spinal Column Injury; Unspecified Infection

  MAUDE report 8517265 ↗