Argyle 8888501031Recalls & reported problems
Cardinal Health, Inc. · Flexible Yankauer,Sump Tip, Regular Capacity with Vent · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884527019854), received between May 4, 2022 and May 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT DURING ROUTINE MOUTHCARE, WHILE SUCTIONING THE PATIENT WITH A YANKAUER, THE TIP OF THE YANKAUER CAME OFF. THE SUMP TIP WAS WHAT BROKE OFF THE PRODUCT. THE PIECE WAS LOST IN THE PATIENT'S OROPHARYNX AND UNABLE TO RETRIEVE OR VISUALIZE IT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PATIENT WAS ALREADY SCHEDULED FOR AN ENDOSCOPIC PROCEDURE, SO A PLAN WAS MADE TO LOOK FOR THE TIP DURING THAT PROCEDURE. DURING THE PROCEDURE, IT WAS UNABLE TO VISUALIZE THE TIP IN THE OROPHARYNX. THE ENDOSCOPIC PROCEDURE WAS ALREADY SCHEDULED FOR ANOTHER UNDERLYING CONDITION, AND NOT SPECIFIC TO THE TIP REMOVAL. THE PATIENT PASSED AWAY ON (B)(6) OF 2025. PER CUSTOMER, AT THIS TIME, THEY ARE UNABLE TO CONFIRM OR EXCLUDE CORRELATION BETWEEN THE DEVICE MALFUNCTION AND PATIENT¿S DEATH.
Patient problems: Foreign Body In Patient
MAUDE report 22015180 ↗MalfunctionMay 4, 2022Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT DURING A THORACOSCOPY, DURING NORMAL USE OF THE SUCTION CUP, A PIECE OF THE BASKET BROKE OFF AT THE TIP IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 14279348 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.