Sage 6145Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00618029821515), received between Oct 22, 2024 and Jun 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 25, 2025Material Separation; Material Separation

  REPORT RECEIVED OF A SUCTION SWAB DISENGAGEMENT. THE REPORTER, A REGISTERED NURSE, STATED SHE WAS PERFORMING ROUTINE ORAL CARE ON 74-YEAR-OLD MALE PATIENT WHO WAS ALERT BUT CONFUSED AND WAS NOT RECEIVING ANYTHING BY MOUTH. THE REPORTER STATED AFTER ABOUT THREE TO FOUR SECONDS OF CLEANING THE PATIENT'S ORAL CAVITY AND WHILE SHE WAS USING THE DEVICE TO CLEAN THE PATIENT'S TEETH, THE SWAB HEAD SLIPPED OFF THE PLASTIC STICK. REPORTER STATED THE FOAM DISENGAGED ALL IN ONE PIECE AND NO PIECES OF FOAM REMAINED ON THE STICK. THE REPORTER STATED THIS EVENT OCCURRED WITH INITIAL USE OF THE DEVICE. THE PATIENT WAS ABLE TO OPEN THEIR MOUTH SO THE REPORTER COULD RETRIEVE THE DISENGAGED FOAM FROM THE PATIENT'S ORAL CAVITY WITH HER FINGERS. SHE STATED THE PATIENT WAS NOT INTUBATED AND DID NOT HAVE ANY HARDWARE IN THEIR MOUTH THAT WOULD HAVE CAUSED THE FOAM TO DISENGAGE. SHE STATED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THE REPORTER PROVIDED PHOTOGRAPHS AND LOT INFORMATION FOR THE AFFECTED DEVICE. ALTHOUGH REQUESTED, THE REPORTER DID NOT RETURN THE AFFECTED DEVICE. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327977 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439198 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  REPORT RECEIVED OF A SWAB DISENGAGEMENT. REPORTER STATED FOAM ON THE SUCTION SWAB DISENGAGED IN ONE PIECE INTO THE PATIENT¿S MOUTH. THE PATIENT WAS A 30-YEAR-OLD MALE AND WAS ORALLY INTUBATED. IT IS UNKNOWN WHEN EXACTLY THE SWAB BECAME DISENGAGED IN THE PATIENT¿S MOUTH. THE DISENGAGED SWAB WAS DISCOVERED WHEN THE PATIENT EXPECTORATED IT. THE PATIENT EXPERIENCED COPIOUS SECRETIONS FOR 3-4 DAYS BEFORE EXPECTORATING THE SWAB. THE SECRETIONS DISSIPATED AFTER THE SWAB WAS EXPECTORATED. THIS LED THE REPORTER TO CONCLUDE THAT THE SWAB CONTRIBUTED TO THE PATIENT¿S COPIOUS SECRETIONS, AND THEREFORE DELAYED HIS EXTUBATION. HOWEVER, THE CIRCUMSTANCES AT THE TIME OF THE SWAB DISENGAGEMENT ARE NOT KNOWN, AS THE EVENT WAS NOT REPORTED BY STAFF AT THE TIME OF THE OCCURRENCE. PER THE REPORTER, AFTER THE PATIENT EXPECTORATED THE SWAB HEAD, THE SECRETIONS DISSIPATED, THE PATIENT WAS SUCCESSFULLY EXTUBATED AND TRANSFERRED FROM THE ICU TO A STEP-DOWN UNIT. THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. THE DEVICE HAS BEEN DISCARDED AND PHOTOS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510302 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  REPORT RECEIVED OF A SWAB DISENGAGEMENT. REPORTER STATED WHILE PERFORMING ORAL CARE ON A MALE, INTUBATED PATIENT, THE FOAM ON THE SUCTION SWAB DISENGAGED IN ONE PIECE INTO THE PATIENT¿S MOUTH. REPORTER STATED THE PATIENT DID NOT BITE DOWN ON THE DEVICE. THE EVENT OCCURRED DURING THE INITIAL USE OF THE DEVICE. A NURSE WAS ABLE TO REMOVE THE PIECE OF FOAM FROM THE PATIENT¿S MOUTH WITH THEIR FINGERS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. THE DEVICE HAS BEEN DISCARDED AND PHOTOS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510130 ↗