Provox Vega 22.5Fr 10mm 8285Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791010897), received between Dec 14, 2023 and Dec 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT STATED THAT HE/SHE HAS STARTED TO HAVE AN ISSUE OF VP DISLODGEMENT INTO THE FOOD PATH SIDE 3 TIMES IN 1 MONTH WHILE EATING FOOD. DISLODGEMENT OF VOICE PROSTHESIS OCCURRED WHEN PATIENT WAS EATING MEALS AND AT THE TIME OF COUGHING. THIS REPORT IS FOR THE FIRST DISLODGEMENT. THE DETAILS ARE AS FOLLOWS: FIRST DISLODGEMENT: (B)(6) 2024. SECOND DISLODGEMENT: ABOUT 1 WEEK AFTER (B)(6) 2024. THIRD DISLODGEMENT: (B)(6) 2024. THE DOCTOR MENTIONED THAT THE PATIENT HAS LOST SOME WEIGHT RECENTLY. USERS SUFFERED NO HARM IN CONNECTION WITH THIS COMPLAINT, HOWEVER, MEDICAL INTERVENTION WAS REQUIRED FOR CHECKING WHERE THE VP WAS BY MEANS OF X-RAY. IT WAS CONFIRMED THAT VP WAS IN THE STOMACH EACH TIME. LOT NUMBER IS NOT KNOWN. IT IS CONFIRMED THAT THE BOX HAS BEEN DISCARDED. ADDITIONAL INFORMATION 26 NOVEMBER: THE DISLODGEMENT OCCURRED DURING EATING MEALS AT THE TIME OF COUGHING. THE 1ST TIME REINSERTED 10 MM VEGA VP AND CHECKED IF THE VP IS INSIDE THE STOMACH BY MEANS OF X-RAY. THE 2ND TIME REINSERTED 12.5MM VEGA VP. THE 3RD TIME REINSERTED 10MM VEGA XTRASEAL VP. THE DOCTOR STATED THAT THE PATIENT CLAIMED INCREASED PRODUCTION OF MUCUS DURING EATING.

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

  MAUDE report 20910953 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROVOX VEGA 22.5 FR 10 MM WAS DISLODGED INTO THE ESOPHAGUS SIDE WHILE THE PATIENT WAS HOSPITALIZED. THE INCIDENT REQUIRED MEDICAL INTERVENTION. (B)(6) 2023: WHILE THE PATIENT WAS EATING AT THE HOSPITAL (UNKNOWN BREAKFAST, LUNCH OR DINNER), THE INDWELLED VOICE PROSTHESIS WAS DISLODGED INTO THE PATIENT'S ESOPHAGUS SIDE. THE PATIENT CALLED A NURSE FOR HELP BY HIM/HERSELF. THE DOCTOR CAME AND CONFIRMED THAT THE VOICE PROSTHESIS WAS STUCK IN THE ESOPHAGUS AND WAS TAKEN OUT BY MEANS OF AN ENDOSCOPE. THE ACTUAL VOICE PROSTHESIS (REF 8285) WAS DISPOSED BY THE HOSPITAL BECAUSE THE HOSPITAL DETERMINED NOT TO REPORT THIS AS AN INCIDENT INTERNALLY. 12/01/2023: A SALES REPRESENTATIVE FROM ATOS MEDICAL VISITED THE HOSPITAL TO HEAR ABOUT THE INCIDENT. THE INCIDENT WAS DISCUSSED WITH DOCTOR AND HEAD NURSE WHICH CONFIRMED THAT THE VOICE PROSTHESIS HAD NOT LEAKED AT ALL AND WAS NOT BROKEN - LOOKED IN A GOOD CONDITION. THEREFORE, IT WAS DETERMINED THAT IT WAS NOT CAUSED BY THE PRODUCT AND THE VOICE PROSTHESIS WAS DISPOSED. THE VOICE PROSTHESIS WAS INDWELLED CLOSER TO, AND JUST BESIDE THE STOMA, BECAUSE THE PATIENT HAD A KUCYO SAIKEN PROCEDURE AND THERE WAS NOT AN OPTION OF A GOOD POSITION FOR MAKING

  Patient problems: Foreign Body In Patient

  MAUDE report 18324824 ↗