Titan ES2920Recalls & reported problems

Coloplast A/S · Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump · Class 3 · Implant

All models of Titan (62)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Quick summary

This Coloplast Titan Touch inflatable penile implant appears in 865 adverse event reports, with 766 injuries and no deaths. Many describe tubing cracking or breaking, fluid leaks, and unexpected inflation, with some mentioning infections and implants that had to be removed and replaced. One open recall, started in March 2023, concerns pumps with thinner walls that may fail sooner than standard pumps.

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: 862
Deaths reported: 0
Injuries reported: 763
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 862 adverse event reports that list this exact device (DI 05708932539197), received between Jul 21, 2017 and Jul 8, 2026 — classified as 763 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Fracture” (177 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1370-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Device problems

Fracture177
Adverse Event Without Identified Device or Use Problem123
Fluid/Blood Leak98
Insufficient Device Problem Information91
Inflation Problem68
Pumping Problem56
Inadequacy of Device Shape and/or Size48
Break45

Patient problems

No Clinical Signs, Symptoms or Conditions489
Unspecified Infection96
No Information94
Erosion38
Failure of Implant23
No Consequences Or Impact To Patient23
No Known Impact Or Consequence To Patient21
Pain21

Recent adverse event reports

The 25 most recent of 862 reports, in the reporter's own words as published by the FDA.

InjuryJul 8, 2026Self-Activation or Keying
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO AUTO INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749238 ↗
InjuryJul 8, 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 25748822 ↗
InjuryJun 23, 2026Adverse 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 25600057 ↗
InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) A COUPLE OF DAYS LATER DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25587348 ↗
InjuryJun 22, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A CRACK IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25587112 ↗
InjuryJun 22, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A BREAK IN TUBING AT PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25584558 ↗
InjuryJun 19, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A POSSIBLE TUBE FRACTURE FROM PUMP. THE FRACTURE WAS NOT VERIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25563366 ↗
InjuryJun 11, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE IN TWO PLACES - ONE ON GRAY TUBING NEAR PUMP, ONE ON CLEAR TUBING FROM CYLINDER TO PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25477983 ↗
InjuryJun 4, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391684 ↗
InjuryMay 11, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A TUBING BREAK AT THE CYLINDER PUMP JUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135534 ↗
InjuryMay 6, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A TUBING FRACTURE FROM PUMP TO CYLINDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25094782 ↗
InjuryMay 5, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT PUMP REMOVED AND REPLACED FOR AN UNSPECIFIED REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081915 ↗
InjuryMay 5, 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 25081339 ↗
InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE INFLATABLE PENILE PROSTHESIS IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO EROSION.
Patient problems: Erosion
MAUDE report 25068662 ↗
InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25050613 ↗
InjuryApr 28, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018915 ↗
InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24984424 ↗
InjuryApr 22, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A TUBING BREAK BY PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960210 ↗
InjuryApr 21, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS FOR UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942582 ↗
InjuryApr 20, 2026Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EXTRUSION.
Patient problems: Erosion
MAUDE report 24925753 ↗
InjuryApr 20, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING FRACTURE NEAR PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925131 ↗
InjuryApr 17, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE TUBING LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912012 ↗
InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, TITAN IMPLANT REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24903221 ↗
InjuryApr 15, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED WITH GENESIS DUE TO UNKNOWN REASONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889403 ↗
InjuryApr 15, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION IMPLANT REMOVED AND REPLACED DUE TO A TUBING BREAK IN THE MIDDLE BETWEEN CYLINDER AND PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885457 ↗

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-1372-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Z-1374-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Z-1375-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Z-1361-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Z-1362-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
Z-1363-2023 · Mar 1, 2023 · Open, Classified
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Z-1359-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
Z-1371-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Z-1366-2023 · Mar 1, 2023 · Open, Classified
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
Z-1369-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Z-1368-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Z-1365-2023 · Mar 1, 2023 · Open, Classified
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Z-1367-2023 · Mar 1, 2023 · Open, Classified
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Z-1360-2023 · Mar 1, 2023 · Open, Classified
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Z-1373-2023 · Mar 1, 2023 · Open, Classified
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis

…and 2 more.

Device details

UDI-DI	`05708932539197`
Brand	Titan
Model	ES2920
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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All Device, Impotence, Mechanical/Hydraulic devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page