Provox® Vega™ XtraSeal™ 22.5 FrRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791010576), received between Jun 9, 2017 and Jun 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: PATIENT HAS NOW STRONG CONCERNS WHEN TO TRY TO COUGH STRONGLY BECAUSE OF POSSIBLE ASPIRATION/INGESTION. SO HE WOULD LIKE TO KNOW THE POSSIBLE REASON AND COUNTERMEASURE TO THEM. AND HE EXPECT IF ANY FOODS MIGHT CATCH THE ESOPHAGEAL SIDE OF THE EXTRUDED VP. PATIENT'S HISTORY TO EVENT: ON (B)(6) 2017; REPLACED VEGA 22.5FR 8MM INTO NEW ONE (8MM) BECAUSE OF LEAKAGE. (B)(6); REPLACED INTO XTRASEAL 10MM BECAUSE OF LEAKAGE. (B)(6); REPLACED INTO XTRASEAL 12.5MM BECAUSE OF LEAKAGE. A NURSE REMINDED THAT THE NEW VP SEEMED SO LONG THAT IT WAS EXTRUDED TOWARD ESOPHAGEAL SIDE. THE DOCTOR REMINDED THAT THE STATUS OF SHUNT HOLE OF THE PATIENT SEEMED GOOD. (B)(6); DURING DINNER, THE PATIENT GOT STUCK IN HIS THROAT AND (WE ARE NOT SURE EXACTLY) THE VP WAS ASPIRATED/INGESTED ACCIDENTALLY. AT THAT DAY, HE WENT TO THE HOSPITAL TO ASK TO INDWELL ANOTHER NEW VP OF XS 12.5 MM. AS OF TODAY, THE DOCTOR HAS NOT CONFIRMED WHERE THE MISSING VP IS, BUT THERE ARE NO SYMPTOMS RELATED TO ASPIRATION ON THE PATIENT. (B)(6); AT LUNCH, HE CHOKED OVER WHEN HE DRUNK. THE VP WAS ASPIRATED/INGESTED AGAIN. IN THAT AFTERNOON, HE WENT TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6629047 ↗