Portex 101/800/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517076073), received between Jan 4, 2022 and Jun 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING USE, THE CUFF DEGASSING EVENT HAPPENED. THE EVENT OCCURRED DURING PATIENT IN USE/DOSE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161437 ↗
• MalfunctionApr 5, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE DURING PRE-TRIAL CHECK. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051695 ↗
• MalfunctionNov 14, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, "AIR WAS EVACUATED FROM THE CUFF". RESOLUTION AND ADVERSE EFFECTS ARE UNKNOWN. THE REPORTED LOT NUMBER CANNOT BE VERIFIED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS AND VERIFICATION OF REPORTED PRODUCT INFORMATION INVOLVED IN THIS INCIDENT WAS RECEIVED. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18133988 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING TRAINING, WHEN REMOVING THE PURPLE TUBE OBTURATOR THE DISTAL PART OF THE OBTURATOR IS GETTING BLOCKED AND IS DIFFICULT TO REMOVE IT COMPLETELY OUT OF THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13153270 ↗