UltraFill ULTRAFILL, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959032477), received between Sep 27, 2017 and Feb 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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.

• MalfunctionFeb 14, 2018Disconnection; Loose or Intermittent Connection; Loose or Intermittent Connection

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN OXYGEN CYLINDER BECAME DISCONNECTED FROM THE ULTRAFILL DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7270684 ↗
• MalfunctionSep 27, 2017Device Operational Issue; Device Operational Issue

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CYLINDER SEPARATED FROM THE ULTRAFILL DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE UTLRAFILL DEVICE AND CYLINDER WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ULTRAFILL DEVICE WAS TESTED AND WAS FOUND TO OPERATE TO DESIGN SPECIFICATIONS. THE CYLINDER WAS TESTED AND THE FILL FITTING HAS SEPARATED FROM THE POST VALVE. THIS OCCURS WHEN EXCESSIVE FORCE HAS BEEN APPLIED TO TIGHTEN THE FITTING TO THE POINT THE BRASS HAS FRACTURED BUT NOT FULLY SEPARATED FROM THE POST VALVE. VISUAL INSPECTION OF THE CYLINDER WAS COMPLETED BY THE MANUFACTURER. THE MANUFACTURER FOUND EVIDENCE OF MARKINGS CAUSED BY A TOOL USED FOR OVERTIGHTENING OF THE FITTING. THIS OCCURRED IN THE FIELD, NOT DURING MANUFACTURING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6898008 ↗