Sage 6346Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00618029831088), received between Jun 5, 2026 and Jun 5, 2026 — classified as 2 malfunctions.

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

• MalfunctionJun 5, 2026Material Separation

  REPORT RECEIVED ON 05/07/2026 OF A COVERED YANKAUER SOFT TIP DISENGAGEMENT. APPROXIMATELY TWO YEARS AGO - ESTIMATED EVENT DATE (B)(6) 2024 - WHILE A HEALTHCARE PROVIDER ADMINISTERED ORAL CARE, THE YANKAUER TIP DISENGAGED FROM THE DEVICE INTO THE PATIENT'S MOUTH. THE YANKAUER DEVICE WAS PART OF THE CONTINUE CARE ORAL KIT. THE PATIENT HAD ADVANCED ALZHEIMER¿S DISEASE AND HIGH SECRETION LEVELS REQUIRING FREQUENT SUCTIONING, TYPICALLY AT LEAST EVERY HOUR. IT WAS NOTED THAT WHEN THE EVENT OCCURRED THE DEVICE HAD BEEN IN USE FOR 2-3 DAYS. THE REPORTER COULD NOT CLARIFY IF THE PATIENT BIT THE DEVICE DURING THIS EVENT; HOWEVER, THE PATIENT HAS A HISTORY OF FREQUENTLY BITING DURING ORAL CARE AND A BITE BLOCK WAS NOT USED DURING THIS EVENT. FOLLOWING THE DISENGAGEMENT, THE NURSE IMMEDIATELY REMOVED THE DISENGAGED YANKAUER TIP FROM THE PATIENT'S MOUTH. NO FURTHER INTERVENTION WAS REQUIRED, AND PATIENT DID NOT EXPERIENCE A SERIOUS INJURY. NO PRODUCT WAS RETURNED AS IT WAS DISCARDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414382 ↗
• MalfunctionJun 5, 2026Material Separation

  REPORT RECEIVED OF A COVERED YANKAUER SOFT TIP DISENGAGEMENT. THE YANKAUER DEVICE IS PART OF THE CONTINUE CARE ORAL KIT. FOLLOWING COMPLETION OF ORAL CARE, THE DEVICE WAS REMOVED FROM THE PATIENT¿S MOUTH AND OBSERVED TO BE INTACT, WITH NO REPORTED ISSUES DURING USE. THE SEPARATION OF THE TIP OCCURRED DURING POST-USE HANDLING WHILE THE CAREGIVER WAS CLEANING THE DEVICE WITH ALCOHOL PADS. IT WAS NOTED THAT WHEN THE EVENT OCCURRED THE DEVICE HAD BEEN IN USE FOR 2-3 DAYS. THE REPORTER COULD NOT CLARIFY IF THE PATIENT BIT THE DEVICE PRECEDING THIS EVENT; HOWEVER, THE PATIENT HAS A HISTORY OF FREQUENTLY BITING DURING ORAL CARE AND A BITE BLOCK WAS NOT USED WITH THE AFFECTED DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO PRODUCT WAS RETURNED AS THE DEVICE WAS DISCARDED. LOT INFORMATION WAS PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414125 ↗