Titan® Inflatable Penile Prosthesis
Brand(s)
Last updated
Summary
Product
Titan® Inflatable Penile Prosthesis
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Titan® Inflatable Penile Prosthesis |
8806754 |
ES2920 |
Issue
Pump bulbs are manufactured using 2 molds. A component on one of the two molds shifted during production. This resulted in a gradual build of material on the mold, which gradually decreased wall thickness of the pump. This occurred over the course of several weeks, culminating in a period of time (17 September 2022 to 02 December 2022) where pump bulbs were manufactured below the wall thickness specification.
Recall Start Date: October 30, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Coloplast A/S
Holtedam 1, Humlebaek, Denmark, 3050
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74577
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