Titan TouchRecalls & reported problems across all models
Coloplast A/S · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 2 models of Titan Touch by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2025 and Jun 26, 2026 — classified as 9 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (10 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Titan Touch problems
Device problems
- Inadequacy of Device Shape and/or Size10
- Adverse Event Without Identified Device or Use Problem4
- Failure to Deflate2
- Malposition of Device2
- Deflation Problem1
- Fluid/Blood Leak1
- Inflation Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Unspecified Infection4
Titan Touch models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Titan Touch ES2924Device, impotence, mechanical/hydraulic18 reports
- Titan Touch ES2824Device, impotence, mechanical/hydraulic4 reports
Recent Titan Touch adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Patient-Device Incompatibility
ACCORDING TO THE AVAILABLE INFORMATION, TITAN IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO LOSS OF DEXTERITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25639567 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH GENESIS DUE TO MALFUNCTION OF THE PROSTHESIS AND LIKELY AN INFECTION. IT WAS NOTED THE MECHANISM TO DEFLATE THE PROSTHESIS ONLY WORKED AFTER SIGNIFICANT PRESSURE APPLIED AND LIKELY PURULENT FLUID (MOSTLY AROUND THE PUMP) FOUND DURING REVISION. HOWEVER, NO EXTERNAL SIGN OF INFECTION. THIS REPORT CAPTURES THE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24955713 ↗InjuryApr 21, 2026Deflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH GENESIS DUE TO MALFUNCTION OF THE PROSTHESIS AND LIKELY AN INFECTION. IT WAS NOTED THE MECHANISM TO DEFLATE THE PROSTHESIS ONLY WORKED AFTER SIGNIFICANT PRESSURE APPLIED AND LIKELY PURULENT FLUID (MOSTLY AROUND THE PUMP) FOUND DURING REVISION. HOWEVER, NO EXTERNAL SIGN OF INFECTION. THIS REPORT CAPTURES THE DEFLATION PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943856 ↗InjuryApr 13, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO BILATERAL [CYLINDER] CROSS OVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24862188 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT WAS REMOVED AND REPLACED BY A MALLEABLE (GENESIS) DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24808891 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE DUE TO INFECTION. IT WAS NOTED THAT THE DEVICE WAS WORKING AS EXPECTED WITH NO MECHANICAL FAILURE.
Patient problems: Unspecified Infection
MAUDE report 24699274 ↗MalfunctionMar 5, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN DID NOT LIKE THE 14.5CM OF TUBING ON THE PRE-CONNECT DEVICE AS IT CAUSED AN EXCESS BUNDLE OF TUBING IN THE SCROTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24525627 ↗MalfunctionMar 3, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING OF THE PRE-CONNECT DEVICE WAS TOO LONG. NO MODIFICATION WERE MADE THOUGH AND THE DEVICE WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496945 ↗InjuryFeb 24, 2026Insufficient Device Problem Information
AN EXPLANTED DEVICE WAS RECEIVED FOR EVALUATION WITH NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430924 ↗MalfunctionFeb 24, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WOULD LOVE TO SEE THE TUBING OF THE 24 SCROTAL PRECONNECT SHORTENED. IT IS WAY TOO LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429866 ↗MalfunctionFeb 23, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE DOCTOR USED THE NEW 24CM PRECONNECTED SCROTAL TOUCH IMPLANT. THE TUBING TO THE PUMP WAS TOO LONG SO HE HAD TO CUT SOME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414066 ↗MalfunctionFeb 19, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION TUBING IS TOO LONG. THE PHYSICIAN MADE IT WORK. HE WAS GOING TO TRIM TUBING BUT ENDED UP LEAVING IT ALONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24391114 ↗MalfunctionFeb 6, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT MEASURED 25CM (PERFECT FOR A 24CM PRECONNECT). THE SURGEON ASKED THE STAFF TO OPEN THE 24CM PRECONNECT TITAN TOUCH. UNFORTUNATELY, AN EXTRA 7 - 10 MINUTES WAS SPENT HAVING TO SHORTEN THE TUBING AND MAKE EXTRA CONNECTIONS. THE DEVICE WAS ULTIMATELY SUCCESSFULLY IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24284188 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS (PLACEHOLDER) DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24028413 ↗MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REPLACED DURING IMPLANT DUE TO A LEAKY CYLINDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827882 ↗
Other Coloplast A/S products
All Coloplast A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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