MEDI-VAC 65652-611Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885380042638), received between Jun 21, 2018 and Nov 24, 2021 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Break; Suction Failure; Break; Suction Failure

  CUSTOMER REPORTED THE CANISTERS ARE BREAKING WITHIN 4 MONTHS THAT THEIR SHELF LIFE IS BECOMING SHORTER. CANISTER LOST SUCTION ON HIGH, LOW OR BOTH AND/OR CRACKED AT THE BASE AND SOMETIMES HAD DECREASED SUCTION DURING UNKNOWN PROCEDURE. CUSTOMER HAS STATED THEY USE (B)(6) WIPES TO CLEAN THEM DOWN AND LEAVE THE CANISTERS ON HIGH SUCTIONS 24/7 AND CLAMP OFF THE TUBING, THEREFORE THE CANISTERS ARE UNDER CONSTANT PRESSURE. THERE WAS NO REPORTED ADVERSE EVENT TO PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872694 ↗
• MalfunctionNov 24, 2021Break; Crack; Suction Problem; Device Markings/Labelling Problem; Suction Failure; Break; Suction Failure

  CUSTOMER REPORTED THE CANISTERS ARE BREAKING WITHIN 4 MONTHS OF USE AND THAT THEIR SHELF LIFE IS BECOMING SHORTER. CANISTER LOST SUCTION ON HIGH, LOW OR BOTH AND/OR CRACKED AT THE BASE AND SOMETIMES HAD DECREASED SUCTION DURING UNKNOWN PROCEDURE. CUSTOMER HAS STATED THEY USE CLINELL WIPES TO CLEAN THEM DOWN AND LEAVE THE CANISTERS ON HIGH SUCTIONS 24/7 AND CLAMP OFF THE TUBING. THERE WAS NO REPORTED ADVERSE EVENT TO PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872601 ↗
• MalfunctionJul 6, 2018Suction Problem

  A (B)(6) PATIENT WAS TREATED FOR AN IDIOPATHIC THORACOLUMBAR SCOLIOSIS OF ADOLESCENCE. IN POST-SURGERY, DURING A GASTRIC ASPIRATION A MEDI-VAC SUCTION SYSTEM, CONNECTED TO CH12 NASOGASTRIC PROBE (FITTING BUCKET) WAS USED. SEVERAL SUCTION SETS AND SEVERAL REGULATORS (DEPRESSION RATE: FROM 0 TO -200 MBAR) WERE USED BY THE NURSES BEFORE OBTAINING THE ASPIRATION. CLINICAL CONSEQUENCES: PROCEDURE DELAYED. PRACTITIONER PERFORMED A MANUAL ASPIRATION USING A SYRINGE. HEALTHCARE PROFESSIONALS WERE DOUBTFUL ON THEIR ABILITY TO ACHIEVE A RAPID AND EFFECTIVE ASPIRATION IN AN EMERGENCY SITUATION. MEASURES: THE DEFECTIVE CANISTERS WERE DISCARDED. DESPITE THE PREVIOUS MEDI-VAC SYSTEM INFORMATION OF USE TO PERSONAL, THE INTENDED USE IS STILL UNKNOWN (NO CANISTER FIXATION, NO REINFORCED TUBING FROM VACUUM SOURCE TO THE CANISTER).

  Patient problems: Aspiration/Inhalation

  MAUDE report 7666814 ↗
• DeathJun 21, 2018Device Inoperable

  (B)(6) PATIENT, HOSPITALIZED FOR THE CARE OF A PATIENT FEBRILE NEUTROPENIA FOLLOWING CHEMOTHERAPY FOR EVOLUTIONARY T-CELL LYMPHOMA. ON THE NIGHT OF (B)(6) TO (B)(6), THE PATIENT HAD A SUDDEN DYSPNEA WITH CARDIOPULMONARY ARREST, TAKEN CARE OF BY A DOCTOR (FROM INTENSIVE CARE UNIT). THE PATIENT VOMITS ABUNDANTLY, CAUSING A DEFECT OF VENTILATION. AN INTUBATION WAS NECESSARY. THE DOCTOR INTENDED TO PERFORM A BRONCHO-ASPIRATION USING THE MEDIC-VAC SYSTEM. THE FACILITY REPORTED THAT THIS WAS NOT POSSIBLE BECAUSE THE SYSTEM DID NOT WORK (NO DEPRESSION IN THE PATIENT'S MANIFOLD). THE USE OF A SECOND SYSTEM PERMITTED TO OBTAIN A SUCTION. CONSEQUENCES : PROCEDURE DELAYED. THE FACILITY REPORTED THAT VENTILATION WAS NOT POSSIBLE DUE TO ASPIRATION DEFECT. THE CARDIO-RESPIRATORY REANIMATION WAS STOPPED DUE TO THE SERIOUS NEUROLOGICAL PROGNOSIS. THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 7627023 ↗