Wayne G56532Recalls & reported problems

Cook Incorporated · Wayne Pneumothorax Set · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002565326), received between Jul 24, 2023 and Sep 29, 2026 — classified as 2 malfunctions.

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
Manufacturing, Packaging or Shipping Problem1
Material Split, Cut or Torn1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934312 ↗
MalfunctionJul 24, 2023Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17377917 ↗

Device details

UDI-DI	`00827002565326`
Brand	Wayne
Model	G56532
Catalog no.	C-UTPT-1020-WAYNE-IMH
Company	Cook Incorporated
Product code	JOL · CATHETER AND TIP, SUCTION
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	Jan 3, 2024

Device type (GMDN): Pleural catheter

A tube designed to be inserted through an intercostal space and into the pleural cavity to establish a channel for the removal of fluid (pleural effusion, blood, chyle), air (pneumothorax), or pus (empyema) to permit full expansion of the lungs typically after surgery or chest trauma. It is typically used with a pleural drainage system that uses a low negative pressure through the drain lumen. Often referred to as a chest tube, it is typically made of silicone and is available in various designs, shapes, and sizes; it may include disposable devices dedicated to catheter introduction, however it does not include fluid collection bags/containers. This is a single-use device.

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