Expel™ Drainage Catheter with Twist-Loc™ Hub H7493931110250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729860594), received between Apr 8, 2019 and Nov 18, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 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.

• InjuryNov 18, 2019Break; Break

  REPORTED VIA MEDWATCH FACILITY# (B)(4). IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN THREE PIECES AND A PIECE WAS LEFT INSIDE PATIENT. A 10.3/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS USED FOR A CHOLECYSTOSTOMY TUBE CHANGE. THE DEVICE WAS FOUND TO BE IN THREE PIECES AND TWO PIECES WERE RETRIEVED. HOWEVER, A THIRD PIECE WAS LEFT IN THE GALLBLADDER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9335036 ↗
• MalfunctionSep 12, 2019Break; Break

  IT WAS REPORTED THAT THE DRAINAGE WAS SEPARATED INTO MULTIPLE PIECES. THE TARGET LESION WAS LOCATED IN THE PERI PANCREATIC AREA. A 10.3/25 EXPEL DRAINAGE CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS SEPARATED INTO MULTIPLE PIECES AFTER THREE WEEKS. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME EXPEL DRAINAGE CATHETER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9009743 ↗
• MalfunctionApr 8, 2019Material Separation; Material Separation

  IIT WAS REPORTED THAT THE SUTURE WAS CUT FROM THE CATHETER. A 10.3/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE DEVICE TO THE TARGET AREA AND WAS SUCCESSFUL. HE ATTEMPTED TO LOOP THE DEVICE BY PULLING THE SUTURE AND HE FOUND SUTURE WAS CUT FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492409 ↗