Argyle 460802Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521067356), received between Jun 24, 2020 and Jun 11, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2021Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE END IS SEALED AND THE TUBE IS SEVERED INTO TWO PIECES. THE ISSUE WAS DISCOVERED PRIOR TO USE. THE TUBING DID NOT APPEAR STUCK IN THE SEAL OF THE PACKAGING. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT, THEREFORE NO HARM, INJURY OR DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987424 ↗
• InjuryJun 24, 2020Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE PATIENT WAS SCHEDULED FOR A VCUG FOR BILATERAL HYDRONEPHROSIS. A 5 FR FEEDING TUBE WAS USED OVER LABEL AS A CATHETER. AFTER IT WAS PLACED, IT WAS NOTED TO BE COILED IN THE BLADDER AND THEY WERE UNABLE TO PROCEED WITH THE PROCEDURE OR REMOVE THE CATHETER. A UROLOGIST IN LUBBOCK WAS CONSULTED WHO PROVIDED SEVERAL SUGGESTIONS ON TECHNIQUES THAT COULD BE EMPLOYED IN ATTEMPTING TO REMOVE THE CATHETER. VARIOUS WIRES WERE PASSED THROUGH THE CATHETER IN AN ATTEMPT TO UNCOIL. THE BLADDER WAS FILLED AND THE CATHETER WAS ADVANCED BACK INTO THE LADDER AND A STIFFER GUIDE-WIRE WAS PASSED THROUGH THE CATHETER TO HELP STRAIGHTEN THE TUBE. LIDOCAINE JELLY WAS USED TO RELIEVE DISCOMFORT AND RELAX THE PROXIMAL SPHINCTER. AFTER APPROXIMATELY AN HOUR THE RADIOLOGIST AND RNP WERE ABLE TO SUCCESSFULLY REMOVE THE CATHETER. THE PATIENT DID NOT REQUIRE FURTHER WORK UP OR TREATMENT. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2020 STATED THAT THE CATHETER WAS CURLED AND KINKED WITHIN THE BLADDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 10192613 ↗