GUARDIAN 65651-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50630140152564), received between Jun 28, 2018 and Jun 28, 2018 — classified as 3 malfunctions.

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.

• MalfunctionJun 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SUCTION CANISTER IMPLODED DURING SURGERY. THE PHYSICIAN WAS HIT IN THE BACK WITH A LARGE PIECE OF CANISTER, BUT WAS NOT HURT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645612 ↗
• MalfunctionJun 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SUCTION CANISTER IMPLODED DURING SURGERY, AND FLUID SPLASHED IN THE TECH¿S EYE. HER EYE WAS FLUSHED WITH WATER AND SHE WAS REFERRED TO EMPLOYEE HEALTH FOR BLOOD EXPOSURE WORK UP INCLUDING TESTING FOR BLOOD BORNE PATHOGEN TESTING. APPARENTLY THE PATIENT WAS (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645601 ↗
• MalfunctionJun 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SUCTION CANISTER IMPLODED DURING SURGERY CAUSING THE PROCEDURE TO BE DELAYED. THE PROCEDURE WAS A C-SECTION, HOWEVER THE BABY HAD ALREADY BEEN DELIVERED. NO KNOWN ISSUES AT THIS TIME FOR THE MOTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645515 ↗