Sof-Flex G14906Recalls & reported problems

Cook Incorporated · Sof-Flex Double Pigtail 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 00827002149069), received between May 9, 2018 and Feb 10, 2022 — classified as 1 injury, 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.

Most reported problems

Device problems

Break1
Device Damaged Prior to Use1

Patient problems

Foreign Body In Patient1
No Consequences Or Impact To Patient1

Recent adverse event reports

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

InjuryFeb 10, 2022Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 13505283 ↗
MalfunctionMay 9, 2018Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT DURING THE KIDNEY TRANSPLANT PROCEDURE, A SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET WAS OPENED ON THE FIELD. THE SCRUB PERSON WAS RE-ADJUSTING THE STENT ONTO THE WIRE WHEN IT WAS NOTED THE END OF THE STENT HAD A CUT ON THE SIDE WHICH WAS MEASURING ABOUT 1.5CM LONG. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7500398 ↗

Device details

UDI-DI	`00827002149069`
Brand	Sof-Flex
Model	G14906
Catalog no.	039512
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.