Argyle 8888256503 (UDI 10884527006427)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884527006427), received between Oct 5, 2020 and Jul 12, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2025Break; Break

  THE CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THE REPLOGLE BLOCKING AND LEAKING FROM THE PIGGY TAIL. PER CUSTOMER, THE PRODUCT HAS BEEN LEAKING CAUSING PATIENT IMPACT OF HAVING TO REPLACE DAILY AND SOMETIMES SEVERAL TIMES PER DAY. IT WAS FLUSHED WITH AIR, BUT IT¿S LIKE THE VALVE WAS BROKEN, SECRETIONS KEPT COMING OUT OF THE TAIL RESULTING IN IMPROPER STOMACH DECOMPRESSION AND PATIENT VOMITING.

  Patient problems: Vomiting

  MAUDE report 22489762 ↗
• MalfunctionJul 12, 2025Break; Break

  THE CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THE REPLOGLE BLOCKING AND LEAKING FROM THE PIGGY TAIL. PER CUSTOMER, THE PRODUCT HAS BEEN LEAKING CAUSING PATIENT IMPACT OF HAVING TO REPLACE DAILY AND SOMETIMES SEVERAL TIMES PER DAY. IT WAS FLUSHED WITH AIR, BUT IT¿S LIKE THE VALVE WAS BROKEN, SECRETIONS KEPT COMING OUT OF THE TAIL RESULTING IN IMPROPER STOMACH DECOMPRESSION AND PATIENT VOMITING.

  Patient problems: Vomiting

  MAUDE report 22489716 ↗
• MalfunctionDec 4, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THEY WENT TO REPLACE THE REPLOGLE SUCTION CATHETER IN THE PATIENT. WHILE PLACING THEY NOTICED PART OF THE TUBE WAS MISSING, AS IF IT HAD BEEN CUT OUT WHICH MEANT THAT THE TUBE COULD NOT FUNCTION. THEY WENT TO GRAB A REPLACEMENT TUBE AND IN THE PACKAGING OF THE FOLLOWING TUBE, THEY FOUND THE PIECE THAT WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845330 ↗
• MalfunctionDec 2, 2024Break; Break

  THE CUSTOMER REPORTED THE REPLOGLE TUBE HAS MALFUNCTIONED AND THE DIMENSIONS OF THE TUBE IN LENGTH AND DIAMETER HAVE BEEN FOUND TO BE INCORRECT AND DIFFERENT TO EXISTING SUPPLY OF REPLOGLES. TUBE WOULD NOT FACILITATE DRAINAGE AND THE END OF THE SUCTION LUMEN WAS VERY SHORT AND SPLITTING WITH THE INSERTION OF A THREE WAY TAP AT THE SUCTION END TO ALLOW CONNECTION TO THE DRAINAGE BAG/SYSTEM. THE BLUE VENT LUMEN IS ALSO OF A DIFFERENT CALIBER THAN EXISTING SUPPLY AND DIFFICULT TO FLUSH SALINE THRU WITH HIGH RESISTANCE NOTED AND POOR DRAINAGE. THE HOSPITAL HAS NOT REPORTED ANY PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818468 ↗
• MalfunctionDec 2, 2024Break; Break

  THE CUSTOMER REPORTED THE REPLOGLE TUBE HAS MALFUNCTIONED AND THE DIMENSIONS OF THE TUBE IN LENGTH AND DIAMETER HAVE BEEN FOUND TO BE INCORRECT AND DIFFERENT TO EXISTING SUPPLY OF REPLOGLES. TUBE WOULD NOT FACILITATE DRAINAGE AND THE END OF THE SUCTION LUMEN WAS VERY SHORT AND SPLITTING WITH THE INSERTION OF A THREE WAY TAP AT THE SUCTION END TO ALLOW CONNECTION TO THE DRAINAGE BAG/SYSTEM. THE BLUE VENT LUMEN IS ALSO OF A DIFFERENT CALIBER THAN EXISTING SUPPLY AND DIFFICULT TO FLUSH SALINE THRU WITH HIGH RESISTANCE NOTED AND POOR DRAINAGE. THE HOSPITAL HAS NOT REPORTED ANY PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818413 ↗
• MalfunctionJul 13, 2023Break; Break

  CUSTOMER REPORTS: THERE WAS AN INCIDENT WITH A REPLOGLE CATHETER. THIS INVOLVED A TEAR IN THE MATERIAL, WHICH WE USE AS A CONNECTING ELEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322378 ↗
• MalfunctionSep 15, 2022Missing Information; Missing Information

  THE CUSTOMER REPORTED THAT THE ITEM WAS DEFECTIVE AND MALFUNCTIONING. PER ADDITIONAL INFORMATION RECEIVED ON FROM THE CUSTOMER ON (B)(6), 2022, THERE WERE NO NUMBER MARKINGS ON THE TUBE. THE NURSE CARING FOR THE PATIENT NOTICED AS SHE WAS PREPARING THE EXCHANGE, THAT SHE WAS UNABLE TO MEASURE THE DEPTH APPROPRIATELY. THERE WAS NO MEDICAL INTERVENTION REQUIRED AS THE PRODUCT DID NOT REACH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432718 ↗
• MalfunctionOct 5, 2020Missing Information; Missing Information

  THE CUSTOMER REPORTED THAT CATHETER WAS RECEIVED WITHOUT ANY MARKINGS ON IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10626818 ↗