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Sof-Flex G17852Recalls & reported problems

Cook Incorporated · Sof-Flex Multi-Length Ureteral Stent Set · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002178526), received between Apr 10, 2019 and Jul 30, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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

  • Device Damaged Prior to Use1
  • Material Separation1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 30, 2020Material Separation; Material Separation

    NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 10343225 ↗
  • MalfunctionApr 10, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8500334 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

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