N/A (REF 10135910)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Diagnostic Ultrasound Catheter, 8F · 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 00885825011369), received between Mar 18, 2026 and Mar 18, 2026 — classified as 1 malfunction.

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

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.

MalfunctionMar 18, 2026
NO IMAGE SHOWN WHEN CATHETER WAS PLUGGED. NO PATIENT HARM OCCURRED ANOTHER REPROCESSED AVC NAV CATHETER WAS OPENED TO COMPLETE THE CASE. VENDOR NOTIFIED. MANUFACTURER RESPONSE FOR INTRAVASCULAR ULTRASOUND CATHETER, ULTRASOUND CATHETER REPROCESSED BIOSENSE WEBSTER (PER SITE REPORTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626112 ↗

Device details

UDI-DI	`00885825011369`
Brand	N/A
Model	N/A
Catalog no.	10135910
Company	Stryker Sustainability Solutions, Inc.
Product code	OWQ · Reprocessed intravascular ultrasound catheter
Class	Class 2
FDA submission	K063076
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 14, 2020

Device type (GMDN): Intracardiac ultrasound imaging catheter, steerable, reprocessed

A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to an ultrasound system for image transmission/display. This is a previously used single-use device that has been processed for an additional single-use patient application.

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