Provox Vega 20Fr 6mm 8277Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791010811), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 death, 1 injury.

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

• InjuryFeb 18, 2026Biofilm coating in Device

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER WITH A VOICE PROSTHESIS (VP) PLACED ON (B)(6) 2025 BY A SPEECH LANGUAGE PATHOLOGIST (SLP) FOLLOWING REMOVAL OF A PREVIOUSLY WORN PROSTHESIS. LEAKAGE THROUGH THE DEVICE WAS REPORTEDLY OBSERVED IMMEDIATELY AFTER PLACEMENT. THE SLP ADJUSTED THE TRACHEAL FLANGE BY PULLING IT FORWARD AND ROTATING THE DEVICE, AFTER WHICH LEAKAGE RESOLVED. ON (B)(6) 2025, WHILE THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED BOWEL CONDITION, LEAKAGE THROUGH THE PROSTHESIS WAS AGAIN OBSERVED DURING SUCTIONING AND THE SLP WAS NOTIFIED. ON (B)(6) 2025, THE PROSTHESIS WAS NO LONGER PRESENT AT THE PUNCTURE SITE AND WAS PRESUMED SWALLOWED. IMAGING, INCLUDING X-RAY AND BRONCHOSCOPY, DID NOT IDENTIFY ANY PORTION OF THE DEVICE IN THE LUNGS. A RED RUBBER CATHETER WAS PLACED AT THE PUNCTURE SITE. ON 01/21/2026, THE MANUFACTURER WAS NOTIFIED THAT THE PATIENT PASSED AWAY ON (B)(6) 2026. AT THIS TIME, NO INFORMATION HAS BEEN RECEIVED INDICATING THAT THE DEATH WAS CAUSED BY OR CONTRIBUTED TO BY THE DEVICE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCUR

  Patient problems: Obstruction/Occlusion

  MAUDE report 24380296 ↗
• DeathFeb 18, 2026Biofilm coating in Device

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER WITH A VOICE PROSTHESIS (VP) PLACED ON (B)(6) 2025 BY A SPEECH LANGUAGE PATHOLOGIST (SLP) FOLLOWING REMOVAL OF A PREVIOUSLY WORN PROSTHESIS. LEAKAGE THROUGH THE DEVICE WAS REPORTEDLY OBSERVED IMMEDIATELY AFTER PLACEMENT. THE SLP ADJUSTED THE TRACHEAL FLANGE BY PULLING IT FORWARD AND ROTATING THE DEVICE, AFTER WHICH LEAKAGE RESOLVED. ON (B)(6) 2025, WHILE THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED BOWEL CONDITION, LEAKAGE THROUGH THE PROSTHESIS WAS AGAIN OBSERVED DURING SUCTIONING AND THE SLP WAS NOTIFIED. ON (B)(6) 2025, THE PROSTHESIS WAS NO LONGER PRESENT AT THE PUNCTURE SITE AND WAS PRESUMED SWALLOWED. IMAGING, INCLUDING X-RAY AND BRONCHOSCOPY, DID NOT IDENTIFY ANY PORTION OF THE DEVICE IN THE LUNGS. A RED RUBBER CATHETER WAS PLACED AT THE PUNCTURE SITE. ON (B)(6) 2025, THE MANUFACTURER WAS NOTIFIED THAT THE PATIENT PASSED AWAY ON (B)(6) 2026. AT THIS TIME, NO INFORMATION HAS BEEN RECEIVED INDICATING THAT THE DEATH WAS CAUSED BY OR CONTRIBUTED TO BY THE DEVICE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCU

  Patient problems: Obstruction/Occlusion

  MAUDE report 24378933 ↗