GUARDIAN 65651-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50630140041202), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fitting 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 16, 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.

• InjuryApr 17, 2018Decrease in Suction; Fitting Problem

  THE LID DID NOT FIT PROPERLY TO THE CANISTER RESULTING IN LOSS OF ASPIRATION AND VISIBILITY FOR THE SURGEON DURING ADENOMA PROSTATE SAMPLING PROCEDURE. IT WAS REPORTED THAT THE ADENOMAS WERE MOVING CAUSING INTERNAL BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7438370 ↗
• MalfunctionApr 17, 2018Fitting Problem; Aspiration Issue

  THE LID DID NOT FIT PROPERLY TO THE CANISTER RESULTING IN LOSS OF ASPIRATION AND VISIBILITY FOR THE SURGEON DURING ADENOMA PROSTATE SAMPLING PROCEDURE. IT WAS REPORTED THAT THE ADENOMAS WERE MOVING CAUSING INTERNAL BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7438342 ↗