Titan® (REF EN8918)Recalls & reported problems

Coloplast A/S · Titan Narrow Scrotal Zero Angle 18CM · Class 3 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This is a Coloplast Titan inflatable penile prosthesis. The 42 reports mostly describe the implant being removed and replaced because of erosion, infection, or tubing fractures; none report deaths, and 36 involve injuries. There is one open recall, started March 2023, over a thinner pump wall that could cause the pump to fail early. Reports have risen recently, with 11 in the last 12 months versus 6 in the period before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 42
Deaths reported: 0
Injuries reported: 36
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05708932072649), received between Jul 5, 2018 and May 1, 2026 — classified as 36 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 other recalls cover devices cleared under the same FDA submission (P000006); they may or may not involve this specific model.

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.

Recalls naming this device

Mar 1, 2023Open, Classified
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Z-1366-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem11
Fracture6
Insufficient Device Problem Information5
Fluid/Blood Leak4
Migration3
Inadequacy of Device Shape and/or Size2
Inflation Problem2
Malposition of Device2

Patient problems

No Clinical Signs, Symptoms or Conditions26
Erosion6
Unspecified Infection6
Failure of Implant2
Hernia1
Pain1
Skin Erosion1

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO EROSION.
Patient problems: Erosion
MAUDE report 25057315 ↗
InjuryApr 20, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925280 ↗
InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO EROSION.
Patient problems: Erosion
MAUDE report 24830155 ↗
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A DISTAL EROSION PIN HOLE OPENING.
Patient problems: Erosion
MAUDE report 24716911 ↗
InjuryMar 16, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING FRACTURE BY THE CYLINDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24608556 ↗
InjuryFeb 23, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT RESERVOIR TUBING WAS SHORTENED, NOTHING WAS EXPLANTED/IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24422226 ↗
InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24282690 ↗
InjuryJan 29, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209084 ↗
InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23957264 ↗
MalfunctionNov 18, 2025Material Deformation; Material Deformation
ACCORDING TO THE AVAILABLE INFORMATION, AN ANEURYSM DEVELOPED AFTER MODELING. THE CYLINDER/PUMP SET WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582945 ↗
InjuryNov 18, 2025Device Damaged by Another Device; Pumping Problem; Device Damaged by Another Device; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION A PLICATION STITCH PLACED THROUGH THE RIGHT CYLINDER OF THE IMPLANT CAUSING THE PUMP TO MALFUNCTION. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582815 ↗
MalfunctionAug 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE AVAILABLE INFORMATION, DURING THE IMPLANT PROCEDURE WHEN THE CYLINDER WAS BEING PLACED PROXIMALLY, IT TORE. THE CYLINDER WAS REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742503 ↗
MalfunctionJun 3, 2025Material Deformation; Material Deformation
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS PREPPED AND PLACED IN THE PATIENT. AFTER FOUR ROUNDS OF MODELING, IT WAS NOTICED THAT THE CYLINDER HAD AN ANEURYSM. THE DEVICE WAS REMOVED, AND A NEW CYLINDER SET WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22131988 ↗
InjuryApr 28, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THERE WAS A TUBING FRACTURE FROM THE CYLINDER TO THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917853 ↗
InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20845308 ↗
InjuryDec 3, 2024Collapse; Inflation Problem; Collapse; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BUCKLING UPON INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832500 ↗
InjuryNov 8, 2024Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE PUMP RIDING TOO HIGH IN THE SCROTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646298 ↗
InjurySep 17, 2024Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS REVISED [REMOVED AND REPLACED] FOR PLACEMENT [MAL-POSITIONED].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241362 ↗
InjuryAug 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064775 ↗
InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19780788 ↗
InjuryFeb 27, 2024Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BROKEN TUBING ABOVE THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793561 ↗
InjuryFeb 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO FLUID LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18770529 ↗
InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO DISTAL EROSION.
Patient problems: Erosion
MAUDE report 18504802 ↗
InjuryJun 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO AN UNKNOWN REASON. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17079600 ↗
InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO AN UNKNOWN REASON. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17076115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000006. One submission often covers many models, so check the product and lot details in each record.

Z-1361-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Z-1371-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Z-1368-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Z-1360-2023 · Mar 1, 2023 · Open, Classified
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Z-1362-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
Z-1370-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Z-1374-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Z-1369-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Z-1363-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Z-1365-2023 · Mar 1, 2023 · Open, Classified
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Z-1375-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Z-1364-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
Z-1373-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
Z-1359-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Z-1372-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

…and 2 more.

Device details

UDI-DI	`05708932072649`
Brand	Titan®
Model	Titan
Catalog no.	EN8918
Company	Coloplast A/S
Product code	FHW · Device, impotence, mechanical/hydraulic
Class	Class 3
FDA submission	P000006
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Inflatable penile prosthesis

An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.

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