NA M001481540Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729295846), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTENSE PAIN. A TARGET LESION WAS LOCATED AT KIDNEY. AN EXPEL URETERAL STENT SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, CONS OLD STENT WAS REMOVED WHEN EXCHANGING OF A URETIC STENT AND REPLACED WITH NEW EXPEL STENT, IT WAS PUSHED FURTHER INTO THE KIDNEY WITH THE PUSHER. WHEN THE DR. ATTEMPTED TO REMOVE THE PUSHER, IT GOT STUCK ON THE TIP OF THE STENT. THE DEVICE WAS REMOVED AND PULLED THE WHOLE STENT SYSTEM FROM THE BODY. THEN, THE SECOND STENT WAS BEING INSERTED. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING GREAT PAIN WITHOUT SEDATION AND THE PROCEDURE WENT FROM TWO TO FOUR HOURS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: Pain

  MAUDE report 8470351 ↗