Pressure Sentinel® 2228-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024038776), received between Oct 1, 2020 and Aug 3, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 16, 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.

• MalfunctionAug 3, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114533 ↗
• MalfunctionFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT IT FRACTURED. THERE WAS NO FOREIGN BODY RETAINED OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457975 ↗
• MalfunctionMar 29, 2021Fracture; Fracture

  NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581784 ↗
• MalfunctionOct 1, 2020Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613820 ↗