Argyle 8888501015Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884527019830), received between Oct 30, 2019 and Oct 29, 2025 — classified as 1 injury, 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT ON THE EVENING OF (B)(6) 2025, ANESTHESIA USED A YANKAUER SUCTION AT THE END OF THE CASE. AFTER THE PATIENT WAS DISCHARGED HOME, SHE ADMITTED TO HAVING SOME IRRITATION AND DIFFICULTY SWALLOWING. AFTER GOING TO BED THAT NIGHT, SHE WOKE UP COUGHING AND THE BLUE TIP FROM THE YANKAUER WAS IN HER MOUTH. PER CUSTOMER KNOWLEDGE, THE PATIENT HAD NO FURTHER ISSUES AND AGREED TO BRING THE TIP BACK TO THE HOSPITAL.

  Patient problems: Cough; Dysphagia/ Odynophagia; Foreign Body In Patient

  MAUDE report 23417505 ↗
• MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED DURING A TOTAL ABDOMINAL HYSTERECTOMY IN LAPAROTOMY, THE CANNULA BASKET DETACHED IN THE PATIENT'S ABDOMINAL CAVITY, AND WAS PROMPTLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18747629 ↗
• MalfunctionMay 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT ONE OF THE NURSES WAS USING THE COVIDIEN YANKAUER AND THE TIP OF THE DEVICE CAME OFF AND THE PATIENT ALMOST ASPIRATED ON IT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THEY WERE DOING ORAL CARE AND THE PATIENT WAS UNABLE TO FOLLOW DIRECTION, NEEDED SUCTIONING. THE NURSE INSERTED YANKAUER INTO LEFT CHEEK TO SUCTION AND WHEN REMOVED, TIP WAS NOT PRESENT. THE RESPIRATORY THERAPIST (RT) AND REGISTERED NURSE (RN) ASSISTED TO KEEP PATIENT CALM AND HELP OPEN THE MOUTH TO ALLOW THE OTHER RN TO LOOK FOR TIP AND RETRIEVE. THE NURSE WAS ABLE TO RETRIEVE THE TIP FROM PATIENT¿S POSTERIOR ASPECT OF THE ORAL CAVITY NEAR THE OROPHARYNX. PER CUSTOMER, TONGUE DEPRESSOR, FLASHLIGHT AND TWEEZERS WERE USED TO RETRIEVE THE TIP. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED BECAUSE OF THE INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16958095 ↗
• MalfunctionMar 4, 2020Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THAT THE PROBE BECAME BLOCKED DURING THE PROCEDURE, CAUSING AN INADEQUATE BLOOD ASPIRATION AND BLOOD CLOTS. THE DEVICE HAD TO BE CHANGED. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9788509 ↗
• InjuryDec 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE TIP FELL DOWN DURING SURGERY. THE SURGEON MANAGED TO GET IT BACK. NO INJURY ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9476765 ↗
• MalfunctionOct 31, 2019Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THE UNIT IS NOT ADEQUATE TO SUCTION THE BLOOD AND BLOOD CLOTS, DESPITE THE CANNULA BEING CHANGED. THE PATIENT HAD PROLONGED BLEEDING AND INCREASED SEVERE BLOOD LOSS. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Blood Loss

  MAUDE report 9263293 ↗
• MalfunctionOct 31, 2019Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THE UNIT IS NOT ADEQUATE TO SUCTION THE BLOOD AND BLOOD CLOTS, DESPITE THE CANNULA BEING CHANGED. THE PATIENT HAD PROLONGED BLEEDING AND INCREASED SEVERE BLOOD LOSS. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Blood Loss

  MAUDE report 9263276 ↗
• MalfunctionOct 30, 2019Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE PROBE IS OCCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257363 ↗
• MalfunctionOct 30, 2019Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE PROBE IS OCCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257351 ↗