Expel™ Nephroureteral Stent System with Twist-Loc™ Hub H7493935108240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729860938), received between Jul 27, 2020 and Dec 14, 2021 — classified as 1 injury, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 14, 2021Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26NOV2021. IT WAS REPORTED THAT THE DEVICE BECAME STUCK. AN EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS DIFFICULTY ADVANCING THE PLASTIC STIFFENER INTO THE STENT RIGHT OUT OF PACKAGE. THE STENT AND THE STIFFENER WERE BOTH FLUSHED AND WIPED BEFORE INSERTION. A BENTSON WIRE WAS ADVANCED IN THE PLASTIC STIFFENER TO ADVANCE IT ALL THE WAY DOWN. THEN, THE NEPHROURETERAL STENT WAS INSERTED INTO THE PATIENT, BUT WHEN THE TIME CAME TO TAKE THE PLASTIC STIFFENER OUT, IT WOULD NOT COME OUT. THE STENT (WITH THE STIFFENER STUCK INSIDE) WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT SECTION WAS DETACHED/SEPARATED IN THREE SECTIONS (PROXIMAL HUB SECTION, MIDDLE SECTION, AND PIGTAIL SECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001472 ↗
• InjuryApr 12, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT PATIENT BECAME SEPTIC. ON (B)(6) 2021, THE 8.3/24 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS PLACED ON THE PATIENT. HOWEVER, THE DRAIN WAS OBSTRUCTED AND PATIENT BECAME SEPTIC AS A RESULT. DURING THE EXCHANGE ON (B)(6) 2021, THE REPLACEMENT DRAIN WOULD NOT FORM A PIGTAIL AT THE PROXIMAL END. THEY HAD TO REMOVE IT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PHYSICIAN IS CONCERNED THAT THE ORIGINAL DRAIN BECAME OBSTRUCTED SO SOON, ESPECIALLY IN A NU. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 11654206 ↗
• MalfunctionJul 27, 2020Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JUL2020. IT WAS REPORTED THAT THE FLEXIBLE CANNULA BROKE INSIDE THE CATHETER. AN 8.3/24 EXPEL NEPHROURETERAL STENT SYSTEM WITH TWIST-LOC HUB WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FLEXIBLE CANNULA BROKE INSIDE THE CATHETER WHEN THE PHYSICIAN TRIED TO IMPLANT THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CATHETER MIDDLE SECTION WAS DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326501 ↗