Pressure Sentinel® 2228-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024038738), received between Mar 11, 2021 and Jun 19, 2025 — classified as 3 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE END OF THE REAMER DISASSEMBLED DURING A PROCEDURE. THERE WAS NO REPORTED PATIENT HARM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293703 ↗
• InjuryNov 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL ELBOW PROCEDURE, THE FLEXIBLE REAMER INSTRUMENT FRACTURED. THE BROKEN DRILL HEAD WAS UNABLE TO BE REMOVED AND THE SURGEONS OPTED TO LEAVE THE FRAGMENT IN PLACE AS IT DID NOT INTERFERE WITH THE IMPLANT PLACEMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20602824 ↗
• MalfunctionOct 10, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904908 ↗
• InjurySep 7, 2023Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 17699787 ↗
• InjuryJul 19, 2023Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 17349840 ↗
• MalfunctionMar 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER REMOVING THE REAMER FROM THE MEDULLARY CANAL, THE TIP OF THE REAMED SLIPPED OFF FROM THE SHAFT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462721 ↗