Argyle 8888505115 (UDI 10884527019984)Recalls & reported problems
Cardinal Health 200, LLC · Yankauer Open Tip, No Vent · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884527019984), received between Jun 14, 2024 and Feb 10, 2025 — classified as 1 injury, 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Heart Problem1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT DURING A HIP REPLACEMENT PROCEDURE AFTER USING THE YANKAUER, IT WAS IDENTIFIED THAT THE TIP OF THE YANKAUER SUCTION BROKE OFF. THERE WERE ATTEMPTS MADE TO LOCATE THE TIP WITHIN THE BODY CAVITY. AFTER SUFFICIENT IRRIGATION/SUCTION AND MANUAL EXPLORATION OF THE WOUND WAS COMPLETED WITHOUT FINDING THE PIECE IT WAS DECIDED TO CLOSE THE PATIENT. XRAY'S WERE ALSO PERFORMED INTRAOPERATIVELY, THAT SHOWED NO RETAINED DEVICE. THE CONCERN WAS SINCE THIS PIECE WAS PLASTIC, IT MAY NOT SHOW UP ON X-RAY. PER CUSTOMER, TO DATE THE PATIENT HAS NOT HAD TO HAVE A RE-OPERATION OR ANY ILL EFFECTS. THE PATIENT IS CURRENTLY DOING WELL WITH RECOVERY.
Patient problems: Foreign Body In Patient
MAUDE report 21350279 ↗MalfunctionOct 16, 2024Break; Break
THE CUSTOMER REPORTED THAT THE YANKAUER SUCTION BROKE DURING SURGERY IN THE OPERATING ROOM. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20468051 ↗InjuryJun 14, 2024Break; Break
THE CUSTOMER REPORTED DURING A CARDIAC SURGERY INTERVENTION UNDER CEC, WHEN USING THE SUCTION CANNULA, IT BROKE AT THE TIP AND CAUSED A CORONARY SINUS INJURY. THIS RESULTED IN ADDITIONAL PROCEDURES BEING CARRIED OUT DURING THE OPERATION, AND THEREFORE LONGER BYPASS SURGERY FOR THE PATIENT. THE INJURY WAS BROUGHT UNDER CONTROL BY THE SURGEON. POSSIBLE LOT NUMBERS ARE 2312925864 OR 2312925964.
Patient problems: Unspecified Heart Problem
MAUDE report 19536501 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.