Provox Vega 22.5Fr 12.5mm 8286Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07331791010903), received between Dec 12, 2024 and Dec 12, 2024 — classified as 2 injuries.

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 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 THIRD DISLODGEMENT. THE DETAILS ARE AS FOLLOWS: FIRST DISLODGEMENT: ON (B)(6) 2024, SECOND DISLODGEMENT: ABOUT 1 WEEK AFTER ON (B)(6)2024, THIRD DISLODGEMENT: ON (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 20911069 ↗
• 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 SECOND DISLODGEMENT. THE DETAILS ARE AS FOLLOWS: FIRST DISLODGEMENT: ON (B)(6) 2024, SECOND DISLODGEMENT: ABOUT 1 WEEK AFTER (B)(6)2024, THIRD DISLODGEMENT: ON (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 20910967 ↗