Balloon2 MH-303 (UDI 04953170053870)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170053870), received between May 4, 2023 and Aug 31, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 31, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED THE NON-STERILIZED BALLOON MAY HAVE BEEN USED DURING A DIAGNOSTIC ENDOSCOPIC ULTRASOUND. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660605 ↗
• MalfunctionMay 4, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED, AN ISSUE OF "MISHANDLING, DUE TO UNLISTED PACKAGE INSERTS AND UNSTERILIZED USE". THE CUSTOMER DID NOT READ THE STERILIZATION INSTRUCTIONS. AND THE DEVICE MAY NOT HAVE BEEN STERILIZED AS THE CUSTOMER CLAIMED. NO INSTRUCTION WAS RECEIVED TO STERILIZE THE DEVICE. CLAIMED THAT EACH PACKAGE DID NOT INCLUDE INSTRUCTIONS TO STERILIZE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED, DUE TO MISHANDLING ISSUE AND UNSTERILIZED USE. THIS EVENT INCLUDES TWO (2) REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (MAJ-213) - BALLOON, REPORT WITH PATIENT IDENTIFIER (B)(6) (MH-303) - BALLOON. THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (MH-303) - BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873689 ↗