Titan® Titan Touch (REF EN2916)Recalls & reported problems
Coloplast A/S · Titan Touch Narrow Base Scrotal Zero Angle 16cm · 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
The Titan Touch is a Coloplast inflatable penile implant with a pump, placed surgically to treat impotence. Its 54 reports mostly describe fluid or blood leaking from the implant, infection, erosion where the implant wears into surrounding tissue, and pumps that stick or will not fully inflate; 51 reports involved injuries and there were no deaths. One recall, opened in March 2023 and still open, says the thinner pump wall can fail prematurely after repeated inflations.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 05708932072557), received between Apr 9, 2019 and Jun 24, 2026 — classified as 51 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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-1363-2023 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem16
- Fluid/Blood Leak15
- Insufficient Device Problem Information7
- Fracture3
- Inadequacy of Device Shape and/or Size3
- Inflation Problem2
- Malposition of Device2
- Physical Resistance/Sticking2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Unspecified Infection15
- Erosion7
- No Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Purulent Discharge1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED FOR AN UNSPECIFIED REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612738 ↗InjuryMay 7, 2026Unintended Deflation
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO ISSUES. IT WOULD INFLATE AND SLOWLY DEFLATE [AUTO-DEFLATION].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113162 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS DUE TO EROSION.
Patient problems: Erosion
MAUDE report 24248098 ↗InjuryJan 7, 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 23989652 ↗MalfunctionDec 29, 2025Material Deformation; Material Deformation
ACCORDING TO THE AVAILABLE INFORMATION THE DOCTOR IMPLANTED 16CM NARROW CYLINDERS WITH 2CM REAR TIP EXTENDERS IN A PATIENT THAT HAD PEYRONIE'S DISEASE WITH A CURVATURE OF 45 DEGREES. MANUAL MODELING WAS PERFORMED FOR 90 SECONDS. DOCTOR NOTICED A BUBBLE HERNIATION (ANEURYSM) ON THE CYLINDER FORMED ON THE PROXIMAL END NEAR THE CLEAR TIP. THE CYLINDER WAS REMOVED AND REPLACED WITH 18CM NARROW CYLINDERS. MANUAL MODELING WAS PERFORMED AGAIN AND AFTER 90 SECONDS, DOCTOR NOTICED A SIMILAR BUBBLE HERNIATION (ANEURYSM) ON THE 18CM NARROW CYLINDERS AT THE PROXIMAL END NEAR THE CLEAR TIP. THE CYLINDER WAS REMOVED AND REPLACED WITH 18CM STANDARD CYLINDERS. THESE WERE SUCCESSFULLY IMPLANTED. MANUAL MOLDING WAS ATTEMPTED WITH NO SUCCESS. THE DOCTOR PROCEEDED TO PERFORM A PLICATION PROCEDURE. THE CASE WAS COMPLETED FOLLOWING PLICATION PROCEDURE WITH NO FURTHER PROBLEMS. THIS REPORT CAPTURES THE 16CM NARROW CYLINDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905756 ↗InjuryNov 18, 2025Inadequacy of Device Shape and/or Size; Malposition of Device; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Malposition of Device; Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION A REVISION PROCEDURE WAS PERFORMED TO UNSTICK THE PUMP AND SHORTEN THE TUBING SO THE PUMP STAYS IN PLACE BETTER. THE DEVICE REMAINS IN SITU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582929 ↗InjuryJul 22, 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 22566545 ↗MalfunctionJun 12, 2025Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE PATIENT TRIES TO INFLATE THE IMPLANT, THE PATIENT CAN ONLY SQUEEZE THE INFLATION BULB ABOUT 4 TIMES BEFORE IT BECOMES ROCK HARD AND THEN CANNOT INFLATE ANY FURTHER. THE PATIENT CANNOT GET AN ERECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22193532 ↗InjuryMar 18, 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 PUS [INFECTION] AND IMPENDING SCROTAL PUMP EROSION.
Patient problems: Erosion; Purulent Discharge; Unspecified Infection
MAUDE report 21632510 ↗InjuryFeb 11, 2025Inflation Problem; Air/Gas in Device; Inflation Problem; Air/Gas in Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE DUE TO AIR IN THE PUMP, CAUSING THE IMPLANT TO NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355835 ↗InjuryAug 15, 2024Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BEING OUT OF POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990460 ↗InjuryJul 26, 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 WITH A MALLEABLE DEVICE DUE TO THE TUBING PROTRUDING THROUGH THE SCROTUM AND INFECTION.
Patient problems: Erosion; Unspecified Infection
MAUDE report 19841218 ↗InjuryJul 15, 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 ON THE RIGHT CYLINDER.
Patient problems: Erosion
MAUDE report 19742714 ↗InjuryJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS PREPPED AND CYCLED ON THE BACK TABLE WITH NO LEAKS OR ISSUES NOTED. THE DEVICE WAS THEN IMPLANTED AND SEATED PROXIMALLY WHERE THE PATIENT HAD THICK PLAQUE FROM PEYROINE'S DISEASE. THE CORPOROTOMY WAS THEN SUTURED CLOSED; HOWEVER, WHEN THE DEVICE WAS CYCLED AGAIN, BLOOD WAS SEEN IN THE SYRINGE INDICATING A LEAK. THE CORPOROTOMY WAS THEN OPENED BACK UP AND THE DEVICE WAS REMOVED. A LEAK WAS IDENTIFIED AT THE JUNCTURE OF THE NARROW BASE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558011 ↗InjuryJun 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19503548 ↗InjuryMay 24, 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 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19392808 ↗InjuryMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION AND MILD INFECTION SYMPTOMS.
Patient problems: Unspecified Infection
MAUDE report 19351199 ↗InjuryApr 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213055 ↗InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A PUMP INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19202432 ↗InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19182004 ↗InjuryApr 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19142751 ↗InjuryApr 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19137795 ↗InjuryApr 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19088500 ↗InjuryMar 26, 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 DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 18982385 ↗InjuryMar 20, 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 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 18942740 ↗
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-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; 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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