Cook G16705Recalls & reported problems

Cook Incorporated · Urodynamic Loop Catheter Dual Lumen · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00827002167056), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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

Device Contaminated During Manufacture or Shipping1

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.

MalfunctionOct 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE PACKAGING OF A URODYNAMICS LOOP CATHETER. AN IMAGE WAS PROVIDED CONFIRMING FOREIGN BLACK MATERIAL WITHIN THE PACKAGING. THE FOREIGN MATTER WAS FOUND BY THE DISTRIBUTOR, AND THE PRODUCT WAS UNUSED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407264 ↗

Device details

UDI-DI	`00827002167056`
Brand	Cook
Model	G16705
Catalog no.	020243
Company	Cook Incorporated
Product code	FAP · CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 17, 2020

Device type (GMDN): Urodynamic manometric catheter, non-electronic

A sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed is typically the infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in urodynamic examination equipment. This is a single-use device.

Other CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE devices

Cook G15540
Cook Incorporated · CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE
2 reports
Cook G15429
Cook Incorporated · CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE
1 report
Cook G16987
Cook Incorporated · CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE
1 report

All CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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