Titan ES2822Recalls & reported problems
Coloplast A/S · Titan® Touch Infrapubic 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 penile implant is an inflatable penile prosthesis used to treat erectile dysfunction. Its 150 adverse event reports include 133 injuries and no deaths, and many describe fluid leaks, fractured parts, pump problems, and implants removed and replaced. The 1 recall, open and begun in March 2023, concerns pump walls thinner than standard that could fail early with repeated use.
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
- 149
- Deaths reported
- 0
- Injuries reported
- 132
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 05708932539142), received between Jul 24, 2017 and Jun 1, 2026 — classified as 132 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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
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-1368-2023 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak21
- Adverse Event Without Identified Device or Use Problem19
- Fracture18
- Pumping Problem13
- Inadequacy of Device Shape and/or Size10
- Inflation Problem10
- Insufficient Device Problem Information8
- Migration8
Patient problems
- No Clinical Signs, Symptoms or Conditions86
- No Information22
- Unspecified Infection14
- Erosion8
- No Consequences Or Impact To Patient5
- No Code Available4
- No Known Impact Or Consequence To Patient3
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2026Material Twisted/Bent; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, A REVISION PROCEDURE WAS PLANNED FOR AN UNSPECIFIED ISSUE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED ON 5/12/2026: THE PATIENT HAD A TITAN IN SITU FOR 12 YEARS. THE IMPLANT HAD BEEN FUNCTIONING PERFECTLY EXCEPT FOR SOME BOTHERSOME TUBING [TWISTED] AND RECENTLY THE PUMP STUCK OCCASIONALLY, FORCING A HARD PUMP TO INFLATE. GIVEN THE AGE OF THE IMPLANT AND THE FACT THAT THE TUBING WAS QUITE COILED, THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354833 ↗InjuryMay 6, 2026Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO PATIENT UNABLE TO PUMP UP THE PUMP AS IT WAS ROCK HARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25094458 ↗InjuryMay 5, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081085 ↗InjuryApr 24, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, A REVISION PROCEDURE WAS PERFORMED DUE TO A LEAK AT THE TUBING CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983967 ↗InjuryApr 16, 2026Material Frayed
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO FRAY IN THE PUMP TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903308 ↗MalfunctionMar 12, 2026Self-Activation or Keying
ACCORDING TO THE AVAILABLE INFORMATION PATIENT REPORTED DEVICE WOULD INFLATE 10 MINUTES AFTER DEFLATION. DOCTOR STATES THAT AUTO INFLATE VALVE WAS DEFECTIVE, SURGERY DATE PENDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578706 ↗InjuryFeb 25, 2026Insufficient 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 24443679 ↗InjuryFeb 20, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401844 ↗MalfunctionFeb 6, 2026Filling Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, DURING A VIRGIN IMPLANT SURGERY, THE IMPLANT WAS UNABLE TO FILL AND MAINTAIN SALINE IN THE PUMP. THEREFORE, IT WAS EXCHANGED DURING THE SURGERY FOR ANOTHER INFLATABLE PENILE PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24282554 ↗InjuryJan 6, 2026Failure to Pump
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED & REPLACED DUE TO THE PUMP NOT PUMPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974842 ↗InjuryDec 19, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23852003 ↗InjuryDec 8, 2025Adverse 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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23750825 ↗InjuryDec 8, 2025Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE SILICON TUBING THAT CONNECTS TO THE PUMP ASSEMBLY EXPERIENCED A BREAKAGE AT THE JUNCTURE POINT BETWEEN THE PUMP AND THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746391 ↗InjuryNov 4, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAK / TUBING FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23464891 ↗InjuryOct 9, 2025Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A MALFUNCTION / MALPOSITION NOTED WITH THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23256981 ↗InjuryOct 8, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23245330 ↗InjuryOct 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23190666 ↗InjuryAug 27, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A FAILURE. IT WAS REPORTED THE SURGEON COULD NOT DETERMINE REASON FOR FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902904 ↗InjuryAug 20, 2025Device Damaged by Another Device; Device Damaged by Another Device
ACCORDING TO THE AVAILABLE INFORMATION, DURING A KIDNEY TRANSPLANT PROCEDURE AND HERNIA SURGERY, THE PUMP AND RESERVOIR WERE DAMAGED. THE PUMP AND RESERVOIR WERE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22848999 ↗InjuryJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAK AT THE PUMP NECK BETWEEN THE PUMP AND RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566680 ↗MalfunctionJul 17, 2025Air/Gas in Device; Air/Gas in Device
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS PREPPED CORRECTLY AND WAS GIVEN TO THE PHYSICIAN TO IMPLANT. UPON TEST INFLATION, THE DEVICE WAS TAKING IN AIR. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529866 ↗InjuryJul 1, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED WITH A SMALLER SIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22370788 ↗InjuryJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22123610 ↗InjuryApr 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE DEVICE BEING EMPTY, CAUSED BY A POSSIBLE LEAK IN THE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21864826 ↗InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO EROSION/EXTRUSION.
Patient problems: Erosion
MAUDE report 21857978 ↗
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-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Z-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
…and 2 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 ES2918Coloplast A/S · Device, Impotence, Mechanical/Hydraulic577 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
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.
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