Titan ClassicRecalls & 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
- 25
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 2 models of Titan Classic by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2025 and Jun 23, 2026 — classified as 7 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (18 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 Classic problems
Device problems
- Inadequacy of Device Shape and/or Size18
- Adverse Event Without Identified Device or Use Problem5
- Fluid/Blood Leak2
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Unspecified Infection3
- Discomfort1
- Pain1
- Perforation1
Titan Classic models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Titan Classic ES8924Device, impotence, mechanical/hydraulic24 reports
- Titan Classic ES8824Device, impotence, mechanical/hydraulic1 report
Recent Titan Classic adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
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 25598628 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25448492 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS. THERE IS NO INDICATION IF ONLY A SINGLE CYLINDER WAS PLACED OR IF A CYLINDER WAS REMOVED AT A LATER DATE; HOWEVER, ON (B)(6) 2026 THE PATIENT ONLY HAD 1 CYLINDER, SO ANOTHER CYLINDER WAS PLACED. THE ASSUMPTION FROM THE FIELD IS THEY BELIEVE THE PATIENT HAD ONLY 1 CYLINDER DUE TO A PERFORATION EITHER DURING THE IMPLANT SURGERY OR AT A LATER DATE THAT CAUSED REMOVAL OF A SINGLE CYLINDER.
Patient problems: Perforation
MAUDE report 25112664 ↗InjuryApr 6, 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 24792099 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO PATIENT DISCOMFORT.
Patient problems: Discomfort
MAUDE report 24640073 ↗MalfunctionFeb 23, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING OF A 24CM PRECONNECT HAD TO BE TRIMMED AS IT WAS TOO LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421704 ↗MalfunctionFeb 20, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION PATIENT WAS MEASURED 24CM. PHYSICIAN ENDED UP USING 22 + 2CM REAR TIP EXTENDER (RTE) INSTEAD OF THE PRE-CONNECT DEVICE BECAUSE THE 24CM TUBING IS TOO LONG. IDEALLY, WOULD HAVE LIKED TO AVOID PUTTING ON RTES BUT SURGEON DID NOT WANT TO TRIM ALL THREE TUBES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404949 ↗MalfunctionFeb 18, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR WILL ONLY USE THE PRECONNECT IF THE PATIENT HAS AN INCREDIBLY LARGE SCROTUM AS THE TUBING LENGTH IS WAY TOO LONG. THE DOCTOR HAS USED IT A COUPLE OF TIMES WITH PATIENTS WITH LARGE SCROTUMS AND HE STILL HAD TO TRIM THE TUBING LENGTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381622 ↗MalfunctionFeb 18, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR WILL ONLY USE THE PRECONNECT IF THE PATIENT HAS AN INCREDIBLY LARGE SCROTUM AS THE TUBING LENGTH IS WAY TOO LONG. THE DOCTOR HAS USED IT A COUPLE OF TIMES WITH PATIENTS WITH LARGE SCROTUMS AND HE STILL HAD TO TRIM THE TUBING LENGTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380919 ↗MalfunctionFeb 18, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR HAS CHOSEN NOT TO USE THE PRECONNECT BECAUSE OF THE TUBING LENGTH. HE WILL ONLY USE IT IF THE PATIENT HAS AN INCREDIBLY LARGE SCROTUM. THE TUBING LENGTH IS WAY TOO LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380095 ↗MalfunctionFeb 4, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING IS FAR TOO LONG. THE PHYSICIAN HAD TO CUT OFF TUBING AND MAKE FURTHER CONNECTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257680 ↗MalfunctionFeb 4, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING IS FAR TOO LONG. THE PHYSICIAN HAD TO CUT OFF TUBING AND MAKE FURTHER CONNECTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257628 ↗MalfunctionJan 6, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE PRE-CONNECT 24CM SCROTAL TUBING HAD TO BE TRIMMED BY 5CM PRIOR TO BEING IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974917 ↗MalfunctionDec 31, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING ON THE NEW 24 CM PRECONNECT IMPLANT WAS 2.75 CM TOO LONG. PHYSICIAN TRIMMED AND RECONNECTED TUBING FROM PUMP TO CYLINDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23937012 ↗InjuryNov 20, 2025Adverse 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 DUE TO PAIN IN SCROTAL AREA. IT WAS NOTED TO BE A POSSIBLE INFECTION.
Patient problems: Pain; Unspecified Infection
MAUDE report 23605477 ↗
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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