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Expel™ Drainage Catheter with Twist-Loc™ Hub H749393410825K1Recalls & reported problems

Boston Scientific Corporation · Nephrostomy Drainage Catheter Kit · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729860891), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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

Device problems

  • Defective Device1
  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2019Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT ON THE DEVICE. AN 8.3/25 K EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB WAS SELECTED FOR USE. IT WAS NOTED THAT THE END OF THE DRAINAGE CATHETER THAT USUALLY PIGTAILS AND CURLS UP HAD MALFUNCTIONED AND HAD A BUBBLE ON THE END OF IT. NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8549852 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.