TitanRecalls & reported problems across all models

Coloplast A/S · 62 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

17 open recalls name at least one Titan model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports: 6,299
Deaths reported: 1
Injuries reported: 5,553
Recalls: 17

We found 62 models of Titan by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 6,299 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2016 and Jul 9, 2026 — classified as 1 death, 5,553 injuries, 745 malfunctions.

The most frequently reported specific device problem is “Fracture” (1,103 reports).

17 FDA recall records name at least one of these models by its device identifier, 17 still open.

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

Last 36 months. The most recent month may be incomplete.

Titan recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1375-2023 · Root cause: Process change control · Recall details · FDA record ↗
Mar 1, 2023Open, Classified
XXX
Z-1374-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1373-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1372-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1371-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1370-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1369-2023 · Root cause: Process change control · Recall details · FDA record ↗
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 ↗
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-1367-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1366-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1365-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1364-2023 · Root cause: Process change control · Recall details · FDA record ↗
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 ↗
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-1362-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1361-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1360-2023 · Root cause: Process change control · Recall details · FDA record ↗
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-1359-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported Titan problems

Device problems

Fracture1,103
Adverse Event Without Identified Device or Use Problem898
Fluid/Blood Leak758
Insufficient Device Problem Information581
Inflation Problem510
Inadequacy of Device Shape and/or Size443
Pumping Problem362
Break318

Patient problems

No Clinical Signs, Symptoms or Conditions3,474
No Information768
Unspecified Infection720
Erosion320
No Consequences Or Impact To Patient184
No Known Impact Or Consequence To Patient183
Pain164
Failure of Implant130

Titan models

62 models, most reported first. Each model has its own page with its reports, recalls and device details.

Titan ES2920
Device, Impotence, Mechanical/Hydraulic
1 recall862 reports
Titan ES2922
Device, Impotence, Mechanical/Hydraulic
1 recall1 death758 reports
Titan ES2918
Device, Impotence, Mechanical/Hydraulic
577 reports
Titan ES8920
Device, Impotence, Mechanical/Hydraulic
1 recall476 reports
Titan ES8922
Device, Impotence, Mechanical/Hydraulic
1 recall334 reports
Titan 517750
Device, Impotence, Mechanical/Hydraulic
1 recall258 reports
Titan ES8918
Device, Impotence, Mechanical/Hydraulic
1 recall225 reports
Titan ES2818
Device, Impotence, Mechanical/Hydraulic
1 recall222 reports
Titan ES8820
Device, Impotence, Mechanical/Hydraulic
1 recall192 reports
Titan ES2820
Device, Impotence, Mechanical/Hydraulic
232 reports
Titan ES2916
Device, Impotence, Mechanical/Hydraulic
1 recall178 reports
Titan ES2822
Device, Impotence, Mechanical/Hydraulic
1 recall149 reports
Titan 90-9000KC
Device, Impotence, Mechanical/Hydraulic
1 recall138 reports
Titan ER8125
Device, Impotence, Mechanical/Hydraulic
166 reports
Titan® Titan Touch
Device, impotence, mechanical/hydraulic
1 recall105 reports
Titan ES8822
Device, Impotence, Mechanical/Hydraulic
151 reports
Titan E17924
Device, Impotence, Mechanical/Hydraulic
132 reports
Titan ES8818
Device, Impotence, Mechanical/Hydraulic
115 reports
Titan® Titan Touch
Device, impotence, mechanical/hydraulic
1 recall54 reports
Titan ES2816
Device, Impotence, Mechanical/Hydraulic
93 reports
Titan®
Device, impotence, mechanical/hydraulic
1 recall42 reports
Titan ESR920
Device, Impotence, Mechanical/Hydraulic
76 reports
Titan ESR918
Device, Impotence, Mechanical/Hydraulic
72 reports
Titan® Titan Touch
Device, impotence, mechanical/hydraulic
1 recall17 reports
Titan ES8916
Device, Impotence, Mechanical/Hydraulic
67 reports
Titan ER8075
Device, Impotence, Mechanical/Hydraulic
66 reports
Titan®
Device, impotence, mechanical/hydraulic
1 recall15 reports
Titan® Titan Touch
Device, impotence, mechanical/hydraulic
1 recall13 reports
Titan ESR922
Device, Impotence, Mechanical/Hydraulic
54 reports
Titan E17926
Device, Impotence, Mechanical/Hydraulic
42 reports
Titan®
Device, impotence, mechanical/hydraulic
41 reports
Titan EN2914
Device, Impotence, Mechanical/Hydraulic
37 reports
Titan ES8816
Device, Impotence, Mechanical/Hydraulic
36 reports
Titan 90-9000KCOTR
Device, Impotence, Mechanical/Hydraulic
29 reports
Titan ESR820
Device, Impotence, Mechanical/Hydraulic
25 reports
Titan ESR818
Device, Impotence, Mechanical/Hydraulic
21 reports
Titan ESR916
Device, Impotence, Mechanical/Hydraulic
20 reports
Titan 90-9918SNC
Device, Impotence, Mechanical/Hydraulic
18 reports
Titan ES8914
Device, Impotence, Mechanical/Hydraulic
17 reports
Titan®
Device, impotence, mechanical/hydraulic
16 reports
Titan ES2914
Device, impotence, mechanical/hydraulic
16 reports
Titan 91-9480SC
Device, Impotence, Mechanical/Hydraulic
15 reports
Titan ES2814
Device, impotence, mechanical/hydraulic
14 reports
Titan ESR822
Device, Impotence, Mechanical/Hydraulic
13 reports
Titan 90-9916SNC
Device, Impotence, Mechanical/Hydraulic
12 reports
Titan E17928
Device, Impotence, Mechanical/Hydraulic
11 reports
Titan ESR816
Device, Impotence, Mechanical/Hydraulic
11 reports
Titan EN2814
Device, Impotence, Mechanical/Hydraulic
11 reports
Titan 519150
Device, impotence, mechanical/hydraulic
8 reports
Titan ES8814
Device, Impotence, Mechanical/Hydraulic
8 reports
Titan 90-9816INC
Device, Impotence, Mechanical/Hydraulic
6 reports
Titan 90-9818INC
Device, Impotence, Mechanical/Hydraulic
6 reports
Titan EN8914
Device, Impotence, Mechanical/Hydraulic
6 reports
Titan 519310
Device, impotence, mechanical/hydraulic
5 reports
Titan 519300
Device, Impotence, Mechanical/Hydraulic
4 reports
Titan EN2911
Device, Impotence, Mechanical/Hydraulic
3 reports
Titan EN8814
Device, Impotence, Mechanical/Hydraulic
2 reports
Titan ENR811
Device, Impotence, Mechanical/Hydraulic
2 reports
Titan EN2811
Device, Impotence, Mechanical/Hydraulic
2 reports
Titan 519300
Device, impotence, mechanical/hydraulic
1 report
Titan ENR814
Device, Impotence, Mechanical/Hydraulic
1 report
Titan ENR914
Device, Impotence, Mechanical/Hydraulic
1 report

Recent Titan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTS A MAJOR CONCERN RELATED TO THE PRESENCE OF VISIBLE AND PALPABLE ¿DOG EARS¿ OR ABNORMAL PROTRUSIONS AFFECTING THE COSMETIC APPEARANCE OF THE PENIS FOLLOWING IMPLANTATION. WHILE ERECTILE RIGIDITY MAY HAVE BEEN RESTORED, THE COSMETIC IRREGULARITIES NEGATIVELY AFFECT SELF-IMAGE, COMFORT, AND SEXUAL CONFIDENCE. PATIENT BELIEVES THAT MORE ATTENTION SHOULD BE DIRECTED TOWARD POST-OPERATIVE PENILE AESTHETICS AND NOT SOLELY TOWARD ERECTILE MECHANICS.
Patient problems: Deformity/ Disfigurement; Discomfort; Emotional Changes
MAUDE report 25770256 ↗
MalfunctionJul 9, 2026Patient-Device Incompatibility; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTS THAT OPERATION OF THE PUMP MECHANISM REQUIRES SIGNIFICANT EFFORT AND OFTEN NECESSITATES THE USE OF BOTH HANDS. THIS CREATES PRACTICAL DIFFICULTIES DURING INTIMATE SITUATIONS AND DIMINISHES SPONTANEITY. THE PATIENT EXPECTED THAT, AFTER RECOVERY, INTIMACY WOULD FEEL MORE NATURAL AND DISCREET. INSTEAD, ACTIVATION OF THE DEVICE FREQUENTLY BECOMES A PHYSICALLY DELIBERATE AND PSYCHOLOGICALLY DISTRACTING PROCESS.
Patient problems: Emotional Changes
MAUDE report 25770225 ↗
InjuryJul 9, 2026Material Frayed
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO THE PUMP TUBING WAS FRAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765535 ↗
InjuryJul 8, 2026Self-Activation or Keying
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO AUTO INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749238 ↗
InjuryJul 8, 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 25749153 ↗
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25748822 ↗
InjuryJul 8, 2026Material Puncture/Hole
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A CYLINDER PUNCTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748580 ↗
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO EROSION.
Patient problems: Erosion
MAUDE report 25747570 ↗
InjuryJul 7, 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 25734585 ↗
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 ↗
InjuryJul 6, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING FRACTURE FROM LEFT CYLINDER TO PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25719937 ↗
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 ↗
InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EROSION.
Patient problems: Erosion
MAUDE report 25717752 ↗
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 ↗
MalfunctionJun 30, 2026Inflation Problem; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT PREVIOUSLY HAD A REVISION ON THE PUMP. NOW POST REVISION, THE PATIENT SAYS HIS DEVICE INFLATES TO ABOUT 98% OF FIRMNESS OF WHAT HE ACHIEVED BEFORE THE REVISION WITH THE FAULTY PUMP, AS WELL AS WHAT HE PERCEIVES A 1 CM LOSS OF LENGTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664747 ↗

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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