CARDINAL HEALTH K86Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885380030157), received between May 13, 2019 and Mar 1, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2023Crack; Suction Failure; Crack; Suction Failure

  THE CUSTOMER REPORTED THE YANKAUERS ARE CRACKED, CAUSING LOSS OF SUCTION. ALSO, THERE IS A SHARP JAGGED EDGE ALONG THE LINE OF THE CRACK THAT COULD CAUSE PATIENT HARM DURING USE. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023, THE YANKAUERS WERE CRACKED BEFORE USE BUT SOME OF THEM WERE NOT NOTICED UNTIL TRYING TO USE THEM. THE STAFF HAD TO OPEN A FEW OF THEM UNTIL THEY LOCATED ONE THAT WAS NOT AFFECTED. THERE WAS NO PATIENT HARM, ONLY A PATIENT SAFETY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459390 ↗
• MalfunctionFeb 6, 2023Crack; Suction Failure; Crack; Suction Failure

  THE CUSTOMER REPORTED THE YANKAUERS ARE CRACKED, CAUSING LOSS OF SUCTION, ALSO THERE IS A SHARP JAGGED EDGE ALONG THE LINE OF THE CRACK THAT COULD CAUSE PATIENT HARM DURING USE. ADDITIONAL INFORMATION RECEIVED STATED THE OR NOTICED THE CRACKS WHEN THEY TRIED TO USE THEM. SOME WERE PLUGGED, NOT JUST CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303149 ↗
• InjurySep 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: DURING A TOTAL HIP REPLACEMENT THE BULBOUS TIP OF THE YANKAUER SUCTION HANDLE BROKE OFF IN THE FEMORAL CANAL AND WAS UNABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15464181 ↗
• MalfunctionSep 20, 2022Break; Entrapment of Device

  THE BULBOUS TIP OF THE YANKAUER SUCTION HANDLE BROKE OFF IN FEMORAL CANAL. UNABLE TO REMOVE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15454372 ↗
• MalfunctionJan 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CLINICAL STAFF REPORTED THAT OVER THE WEEK THE TIP OF A YANKAUER SUCTION DEVICE BROKE DURING USE. THE TIP WAS LODGED IN THE PATIENT¿S AIRWAY AND WAS FORTUNATELY ABLE TO BE REMOVED. STAFF REPORTED THAT THERE ISN'T MUCH FORCE APPLIED DURING THE PROCEDURES AND OTHERS SAID THEY NEVER EXPERIENCED ONE BREAKING BEFORE. THERE WAS NO PATIENT INJURY REPORTED AND IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13293463 ↗
• MalfunctionAug 20, 2019Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT UPON INSPECTION, THEY FOUND OUT THAT THE DEVICE WAS DAMAGED/BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 8911927 ↗
• MalfunctionMay 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE TIP WAS BROKEN OFF THE TOP OF THE SUCTIONS CATHETER AND NOT PRESENT IN THE UNOPENED PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8604707 ↗