Expel™ Drainage Catheter with Twist-Loc™ Hub H7493931112250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729860600), received between Dec 6, 2018 and Nov 3, 2020 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionNov 3, 2020Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON OCTOER 12, 2020. IT WAS REPORTED THAT PROXIMAL PART OF CANNULA SPRING OUT FROM THE CATHETER. A 12/25 EXPEL DRAINAGE CATHETER WITH TWIST-LOC-HUB WAS SELECTED FOR USE. UPON PREPARATION, IT WAS NOTED THAT THE PROXIMAL PART OF THE CANNULA SPRING OUT FROM THE CATHETER WHEN INSERTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HOLE IN THE PIGTAIL SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778341 ↗
• InjuryAug 16, 2019Break; Break

  IT WAS REPORTED VIA MEDWATCH #5087974 THAT A SUTURE DETACHED AND REMAINED INSIDE THE PATIENT CAUSING PERFORATION AND ABDOMINAL ABSCESS. THE TARGET LESION WAS LOCATED IN THE ABDOMEN. A 12/25 EXPEL DRAINAGE CATHETER WAS SELECTED FOR USE TO DRAIN AN INTRAABDOMINAL ABSCESS. THE SUTURE MATERIAL USED TO CURL THE IR CATHETER BROKE OFF IN THE PATIENT'S ABDOMEN THAT LED TO RECURRENT ABSCESS, INFECTION, BOWEL PERFORATION AND SERIOUS LIFE THREATENING MEDICAL PROBLEMS. THERE IS AN ONGOING SURGICAL TREATMENT THAT REQUIRES FURTHER RECONSTRUCTIVE SURGERY. THE BSC EXPEL DRAINAGE CATHETER WITH TWIST LOC HUB 12 FRENCH X 25CM WAS USED LAST 2017 IN WHICH THE LOCKING SUTURE WAS BROKEN OFF AND PERFORATED THE DUODENUM AND SEPSIS THAT WAS LATER IDENTIFIED IN 2018. THERE WERE MULTIPLE OPERATIONS AND THE PATIENT CONTINUES TO HAVE SIGNIFICANT MEDICAL PROBLEMS REALTED TO THE DETACHED SUTURE WHICH CAUSED PERFORATION AND ABDOMINAL ABSCESS. THE PATIENT WAS READMITTED IN 2017 FOR FURTHER TREATMENT OF MULTIPLE ABDOMINAL ABSCESS IN WHICH THE BACK END OF THE DRAIN WAS CUT, THE DRAIN WAS REMOVED OVER A SHORT NON BSC WIRE AND DRAINAGE CATHETER. BLISTERING OF THE SKIN ADJACENT TO THE DRAIN WAS NOTED. THE LOCKING LOOP W

  Patient problems: Abscess; Device Embedded In Tissue or Plaque; Perforation; Sepsis

  MAUDE report 8903902 ↗
• InjuryDec 6, 2018Break; Break

  REPORTED VIA USER MEDWATCH # (B)(4) THAT THE DRAIN FRACTURED AND A PORTION WAS SNARED FROM THE PATIENT. AN EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS USED IN AN ABDOMINAL FLUID COLLECTION DRAINAGE 2 MONTHS AGO. HOWEVER, IT WAS NOTED THAT THE FLUID WAS LEAKING AROUND THE DRAIN AND WAS PLANNED TO BE REPLACED WITH A NEW DRAINAGE IN INTERVENTIONAL RADIOLOGY. THE IMAGES TAKEN REVEALED THAT THE DRAIN WAS FRACTURED AND ONE FRAGMENT WAS RETRIEVED DURING THE INITIAL PROCEDURE. THE PATIENT THEN RETURNED TO THE INTERVENTIONAL RADIOLOGY THE NEXT DAY AND THE OTHER FRAGMENT WAS SNARED AND A NEW DRAIN WAS PLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8138209 ↗