Coloplast Titan Adverse Events: November 2025 FDA MAUDE Submissions

[lasthope2.0]

Coloplast Titan Adverse Events: November 2025 FDA MAUDE Submissions

Summary

• Total Reports Analyzed: 105 (82 after excluding events with undocumented reasons)
• Mechanical Failures: 54 (66% of subset)
• Biological Failures: 28 (34% of subset)
• Mechanical failures occur significantly later (avg 6 years) than biological complications (avg 3.5 years).

Source:
-U.S. Food and Drug Administration
https://www.fda.gov/medical-devices/med ... data-files
-AI tools for extracting stats using Event Text (mistakes possible)
__________________________________________________
1. Detailed Breakdown by Category

A. Mechanical Failures (n=54)

Code: Select all

COMPONENT / ISSUE           COUNT    NOTES
----------------------------------------------------------------------------------
Tubing/Connector Issue      37       Most common. Fractures near pump/cylinder.
Unspecified Fluid Leak      5        "Device empty" - specific leak point unknown.
General Malfunction         5        Generic "mechanical failure" reports.
Pump Issue                  4        Pump stuck, frozen, or auto-inflating.
Cylinder Issue              2        Rare. Aneurysm or cylinder body leak.
Reservoir Issue             1        Rare.


The core components (cylinders and reservoir) are highly reliable. The weak link is consistently the tubing and connections.

B. Biological & Surgical Issues (n=28)

Code: Select all

ISSUE                       COUNT    NOTES
----------------------------------------------------------------------------------
Infection                   8        Leading biological cause for removal.
Sizing/Placement            7        "Too short", "tips not seated", etc.
Erosion/Extrusion           5        Device eroding through tissue.
Pain/Discomfort             5        Chronic pain requiring explant.
Other/Migration             3        Migration, swelling, reactions.


Infections and sizing issues account for over half of all non-mechanical revisions.
__________________________________________________
2. Time-to-Failure (TTF) Analysis

Calculated the "Age of Device" at the time of failure (Event Date - Manufacture Date). The data shows two distinct lifecycles.

Mechanical Failures (Wear & Tear)

• Average Age: 5.94 Years
• Median Age: 6.08 Years
• Range: 2 months to 15.0 years
• These failures follow a standard wear-out curve, peaking around year 6.

Biological Failures (Surgical/Healing)

• Average Age: 3.52 Years
• Median Age: 1.59 Years
• Range: 5 months to 16.3 years
• These occur much earlier. The low median (1.6 years) indicates most are post-surgical complications.

__________________________________________________
3. Summary of Visual Findings

• Dominance of Tubing Issues: Visual analysis confirms tubing fractures dwarf all other mechanical issues combined.
• Timeline Split:
  - Biological events cluster on the left side of the timeline (Early).
  - Mechanical events form a bell curve in the middle/right (Late).
• Component Durability: Cylinders and Reservoirs show the lowest failure rates and often survive longer than the tubing connecting them.

[QuestionGuy]

I am dealing with a Titan failure, and this is very interesting data. When I got impanated, the group-think was that a failure was some kind of a long-shot rare event....but this data makes it seem almost inevitable.

I'm interested in knowing if there is any data on what (statistically) causes most failures (behavior-wise) because over the years, I have seen alot of people here fantasizing : that if they inflate less frequently, they will prolong the devices mechanical life (like a car or something) .....but it seems that almost all failures are the tubing getting pulled out or leaking.....so I think these theories are not valid.

In my case I did 3 things that I am suspicious of:

1) fell asleep inflated (could have rolled onto it in my sleep and put crazy pressure on something)

2) dumbell dead lifts (a new exercise for me.....someting just felt weirds about it)

3) running on a new cheap narrow treadmill (it caused me to really keep my leg's together in a very unnatural stride)

anyway....im very interested in understanding the physics of this, as I don't want to get major surgery every 6 years... and I also don't want to be paranoid about everything for the rest of my life either.