Mallinckrodt 18765Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50884522007588), received between Mar 13, 2017 and Aug 13, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION AND DEFLATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8886512 ↗
• MalfunctionDec 7, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, AIR COULD NOT BE SUPPLIED TO THE CUFF. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7097963 ↗
• MalfunctionMar 13, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT WHERE IT WAS ALLEGED THAT AN AIR LEAK WAS FOUND DURING THE CUFF CHECK. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6401442 ↗