V. Mueller U-0545Recalls & reported problems

Steris Corporation · V. Mueller Neuro/Spine CHROMA-LINE BRAND TAKA inchesM inches SUCTION TUBE, STRAIGHT 5 FR, RED WORKING LENGTH 4-3/4 inches 12CM · Class 2

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 10885403138119), received between Jan 16, 2025 and Jan 16, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1

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.

MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED VIA MEDWATCH REPORT (MW5163223) THAT THEIR NEURO/SPINE CHROMA-LINE BRAND TAKA SUCTION TUBE BROKE DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21172773 ↗

Device details

UDI-DI	`10885403138119`
Brand	V. Mueller
Model	U-0545
Catalog no.	U0545
Company	Steris Corporation
Product code	JOL · CATHETER AND TIP, SUCTION
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 13, 2024

Device type (GMDN): Surgical/emergency suction cannula, non-illuminating, reusable

An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable 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.