Sof-Flex G14866Recalls & reported problems

Cook Incorporated · Sof-Flex Double Pigtail 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 00827002148666), received between Feb 11, 2025 and Feb 11, 2025 — classified as 1 malfunction.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionFeb 11, 2025Break; Break
AS REPORTED, THE USER OF A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FOUND THE STENT WAS SEPARATED IN TWO PIECES IN THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND THE DEVICE WAS NOT USED ON THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21360866 ↗

Device details

UDI-DI	`00827002148666`
Brand	Sof-Flex
Model	G14866
Catalog no.	039614
Company	Cook Incorporated
Product code	FAD · STENT, URETERAL
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	May 1, 2020

Device type (GMDN): Polymeric ureteral stent

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

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