Argyle 36626Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884527002412), received between Oct 25, 2019 and Dec 22, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2020Suction Failure; Suction Failure

  THE RESPIRATORY DEPARTMENT REPORTED THE THERAPIST TRIED 3 SEPARATE SUCTION CATHETERS AND NONE WOULD SUCTION. SHE THINKS THERE MAY HAVE BEEN A SLIT OR HOLE IN THE LINE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057481 ↗
• MalfunctionNov 20, 2019Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT THERE WAS A BLOCKAGE SOMEWHERE IN THE CATHETER WHICH MAKES IT UNABLE TO BE USED. THIS HAS OCCURRED IN MANY FOR LOT NUMBER 1908413364. ADDITIONAL INFORMATION PROVIDED BY THE NICU MANAGER STATED THAT THE ISSUE WAS DISCOVERED WHILE PREPARING TO SUCTION THE PATIENT. THE CATHETER WAS UNABLE TO SUCTION THE PATIENT. THEY CONFIRMED THAT THE PATIENT WAS NOT HARMED BY THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9350234 ↗
• MalfunctionOct 25, 2019Inaccurate Information; Inaccurate Information

  THE CUSTOMER REPORTED THEY EXPERIENCED A CRITICAL PRODUCT ISSUE WHERE THE GRADUATED NUMBERS WERE PRINTED IN REVERSE. THIS ISSUE WAS DISCOVERED PRIOR TO USE IN THE NEWBORN INTENSIVE CARE UNIT.

  Patient problems: No Patient Involvement

  MAUDE report 9239162 ↗
• MalfunctionOct 25, 2019Inaccurate Information; Inaccurate Information

  THE CUSTOMER REPORTED THAT THE NUMBER MARKINGS ON THE CATHETER WERE IN REVERSE ORDER, MAKING IT DIFFICULT TO ENSURE MAINTAINING SAFE SUCTIONING DEPTH. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE CATHETER WAS USED FOR ENDOTRACHEAL TUBE SUCTIONING. THE ISSUE WAS NOTICED DURING USE. NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238831 ↗