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Sof-Flex G14783Recalls & reported problems

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

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 00827002147836), received between May 16, 2017 and May 16, 2017 — classified as 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

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.

  • MalfunctionMay 16, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

    THE CUSTOMER REPORTED THAT THE TIP OF SOF-FLEX MULTI-LENGTH URETERAL STENT SET WAS FOUND BROKEN WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT HARM REPORTED AND NO ADDITIONAL PROCEDURES WERE REQUIRED BECAUSE OF THIS FAILURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6568477 ↗

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.