Titan ES2918Recalls & reported problems
Coloplast A/S · Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Coloplast Titan Touch implant is an inflatable device for erectile dysfunction, filled with fluid by a pump. Its 578 reports include 510 injuries and no deaths, mostly describing fractures, fluid leaks, and inflation or pumping problems, along with infections and erosion. Recent reports describe implants removed and replaced after infections, tubing breaks, or the pump eroding through the scrotum. No recalls name this device.
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
- 577
- Deaths reported
- 0
- Injuries reported
- 509
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 577 adverse event reports that list this exact device (DI 05708932539180), received between Jul 21, 2017 and Jul 7, 2026 — classified as 509 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Fracture” (115 reports).
18 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
Most reported problems
Device problems
- Fracture115
- Fluid/Blood Leak95
- Adverse Event Without Identified Device or Use Problem79
- Inflation Problem55
- Insufficient Device Problem Information52
- Pumping Problem38
- Break29
- Inadequacy of Device Shape and/or Size28
Patient problems
- No Clinical Signs, Symptoms or Conditions329
- Unspecified Infection75
- No Information72
- Erosion26
- No Consequences Or Impact To Patient19
- Bacterial Infection16
- Pain12
- Failure of Implant11
Recent adverse event reports
The 25 most recent of 577 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25732813 ↗MalfunctionJul 6, 2026Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD A POST OP APPOINTMENT AND WAS GIVEN THE GO AHEAD TO START INFLATING/DEFLATING HIS DEVICE. ON ATTEMPTING TO FULLY INFLATE THE DEVICE, THE PUMP SEEMED TO REACH A CERTAIN POINT AND COLLAPSE. THE PATIENT IS STILL ABLE TO INFLATE AND DEFLATE THE DEVICE BUT NOW EVERY TIME HE INFLATES THE DEVICE THE PUMP SEEMS TO GET STUCK OR COLLAPSE. HE HAS AN APPOINTMENT TO FOLLOW UP ON THIS CONCERN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25717955 ↗InjuryJun 30, 2026Adverse 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 25664942 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED WITH A GENESIS DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25594266 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO AN EROSION. THE DEVICE WAS IN WORKING ORDER, JUST THE PUMP ERODED THROUGH THE SCROTUM. A URETHRAL ISSUE [PERFORATION] OCCURRED DURING THE EXPLANT, AND THE DEVICE WAS NOT REPLACED.
Patient problems: Erosion; Perforation
MAUDE report 25449106 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED WITH GENESIS DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25436042 ↗InjuryJun 4, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO BREAK IN CYLINDER TUBING BY PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25400850 ↗InjuryMay 19, 2026Material Frayed
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE TUBING BEING FRAYED ON THE CYLINDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25218553 ↗InjuryMay 12, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, ORIGINAL RESERVOIR WAS PLACED TOO LATERAL, NEW RESERVOIR PUT IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149034 ↗InjuryMay 11, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING. THE IMPLANT WAS TOO SHORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143328 ↗InjuryMay 11, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS REMOVED AND REPLACED DUE TO IT RIDING HIGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136884 ↗InjuryMay 7, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A TUBING FRACTURE FROM THE PUMP TO CYLINDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111735 ↗InjuryApr 23, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW TITAN TOUCH FOR AN UNKNOWN REASON. IT WAS CONNECTED TO EXISTING RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966242 ↗InjuryApr 23, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966034 ↗InjuryApr 17, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A PUMP TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913397 ↗InjuryApr 16, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT WAS REMOVED AND REPLACED FOR UNSPECIFIED REASONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904103 ↗InjuryApr 16, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO LEFT CYLINDER LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896715 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, TITAN IMPLANT WAS REMOVED AND REPLACED WITH GENESIS DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24885608 ↗InjuryApr 8, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A TITAN TOUCH DUE TO A TUBING FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817601 ↗InjuryMar 31, 2026Adverse 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 24741566 ↗InjuryMar 26, 2026Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EXTRUSION.
Patient problems: Erosion
MAUDE report 24700906 ↗InjuryFeb 24, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE IMPLANT CROSSING OVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24433439 ↗InjuryFeb 24, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT (TOUCH) WAS REMOVED AND REPLACED DUE TO A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431276 ↗InjuryFeb 16, 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 24344073 ↗InjuryJan 28, 2026Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE DEVICE NOT FULLY INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201104 ↗
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-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Z-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
…and 3 more.
Other Device, Impotence, Mechanical/Hydraulic devices
- Titan ES2920Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall862 reports
- Titan ES2922Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall1 death758 reports
- Titan ES8920Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall476 reports
- Titan ES8922Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall334 reports
- Titan 517750Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall258 reports
- Titan ES8918Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall225 reports
- Titan ES2818Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall222 reports
- Titan ES8820Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall192 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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