GUARDIAN 65651-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50630140152540), received between Mar 5, 2018 and Jan 5, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Suction 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.

• MalfunctionJan 5, 2022Burst Container or Vessel; Suction Failure; Burst Container or Vessel; Suction Failure

  CUSTOMER REPORTED THE PROCEDURE WAS A PLANNED AIRWAY SUCTIONING. THE CANNISTER WITH SMALL AMOUNTS OF ORAL SECRETIONS SHATTERED IN MULTIPLE LOCATIONS AFTER COMPLETING ROUTINE SUCTIONING OF THE PATIENT. THERE WAS A LOUD BANG HEARD WHEN THE CANISTER BROKE. THE SUCTION CANISTER WAS CONTAMINATED WITH ORAL SECRETIONS WHEN THE PRODUCT LOST ITS SUCTION CAPABILITY. THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT BUT THERE WAS BODILY FLUID EXPOSURE AS A PORTION OF THE CONTAINER DID CONTACT THE INTACT SKIN OF THE PRIMARY RN. THERE WERE NO ADVERSE EFFECTS TO RN. AT PRESENT RN IS DOING FINE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 13172737 ↗
• InjuryMar 5, 2018Suction Problem

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THE CANISTERS PLASTIC WAS FRACTURED AND DID NOT PROVIDE ADEQUATE SUCTION FOR THE PATIENT. PATIENT HAD A NG TUBE TO LOW INTERMITTENT WALL SUCTION. REPORTEDLY DUE TO LACK OF POOR SUCTION THE PATIENT EXPERIENCED VOMITING, RETCHING AND PAIN. PATIENT WAS DISCHARGED ON (B)(6) 2018.

  Patient problems: Pain; Vomiting

  MAUDE report 7314780 ↗
• InjuryMar 5, 2018Fracture; Suction Problem

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THE CANISTERS PLASTIC WAS FRACTURED AND DID NOT PROVIDE ADEQUATE SUCTION FOR THE PATIENT. PATIENT HAD A NG TUBE SET TO LOW INTERMITTENT WALL SUCTION. REPORTEDLY DUE TO LACK OF POOR SUCTION THE PATIENT EXPERIENCED VOMITING, RETCHING AND PAIN. PATIENT WAS DISCHARGED ON (B)(6) 2018.

  Patient problems: Pain; Vomiting

  MAUDE report 7314771 ↗