Argyle 8888256503 (UDI 20884521102443)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521102443), received between Dec 23, 2019 and Dec 16, 2020 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 16, 2020Break; Break

  THE CUSTOMER REPORTED THAT WHEN INSERTING A 10FR ARGYLE REPLOGLE SUCTION CATHETER, THEY MET RESISTANCE AND PULLED THE TUBE BACK OUT. THE ROUNDED FENESTRATED END OF THE TUBE APPEARED TO BE SHEARED OFF RIGHT WHERE THE HOLES WOULD NORMALLY BEGIN. THE CUSTOMER NOTIFIED THE MEDICAL TEAM THAT THERE WAS A CHANCE THE REMAINDER OF THE TUBE WAS BROKEN OFF INSIDE THE PATIENT. THE MEDICAL TEAM ORDERED AN X-RAY TO SEE IF THEY COULD LOCATE THE FOREIGN BODY AS THE PRODUCT IS RADIOPAQUE. THEY WERE UNABLE TO LOCATE ANY SIGN OF A FOREIGN BODY SO THEY ASSUME THE TUBE WAS DEFECTIVE FROM THE MANUFACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015880 ↗
• MalfunctionMar 9, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT AFTER PLACING THE REPLOGLE CATHETER IN A CHILD, THEY WERE NOT ABLE TO PUSH AIR THROUGH THE AIR INTAKE. THEY WITHDREW THE CATHETER AND RETESTED IT. THE CATHETER STILL HAD PERSISTENCE OF RESISTANCE. ANOTHER REPLOGLE CATHETER WAS USED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9807319 ↗
• MalfunctionDec 23, 2019Suction Problem; Suction Problem

  THE CUSTOMER REPORTED THAT THE CATHETER HAS A HOLE. ADDITIONAL INFORMATION RECEIVED ON 23-DEC-2019 STATED THAT THE HOLE PREVENTED THE DEVICE FROM SUCTIONING AND CAUSED AIR TO LEAK FROM THE HOLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511827 ↗