Argyle 8888505172Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884527020010), received between Sep 16, 2020 and Jun 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING DELIVERY FROM THE DISTRIBUTOR TO THE HOSPITAL, WELDED PARTS BECAME DIS-ATTACHED. THE PRODUCT WAS UNUSED. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058277 ↗
• MalfunctionMay 19, 2022Break; Break

  THE CUSTOMER REPORTED DURING ORTHOPEDIC SURGERY, THE YANKAUER WAS USED FOR BLOOD SALVAGE. AFTER THE OPERATION THEY NOTICED THE TIP WAS CHIPPED. THERE WAS NO EFFECT ON THE PATIENT AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434277 ↗
• MalfunctionSep 16, 2020Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE YANKAUER WAS USED DURING CARDIAC SURGERY AND IT WAS UNABLE TO SUCTION. A SECOND YANKAUER WAS OPENED AND USED HOWEVER IT WAS ALSO UNABLE TO SUCTION. THE FLUID REACHED A LITTLE OVER THE BENDING POINT OF THE CATHETER BUT WOULD GET STUCK THERE. THE CATHETER WAS USED AGAIN AND THE SUCTION PRESSURE WAS RAISED BUT NOTHING HAD CHANGED. THE YANKAUER HAD TO BE REPLACED WITH ANOTHER MAKERS CATHETER WHICH SUCTIONED WITHOUT A PROBLEM. IT WAS CONFIRMED THAT THERE WERE NO CLOGS OR ISSUES WITH THE TUBE BETWEEN THE CATHETER AND THE ASPIRATOR. THE TUBE'S SHAPE WAS A LITTLE FLATTENED DURING SUCTIONING. TO VERIFY THERE WERE NO ISSUES WITH THE TUBING THE CATHETER WAS DETACHED FROM THE TUBE AND THE SUCTION WITH THE TUBE WAS CHECKED, THERE WERE NO ISSUES WITH THE TUBE. THE USER UNDERSTANDS BOTH OPERATION PROCEDURE AND STRUCTURE OF THE BLACK CONTROL LEVER, AND THOSE HAD BEEN CHECKED AT THE OPERATING FIELD. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10543703 ↗