Titan® Titan Touch (REF EN2918)Recalls & reported problems
Coloplast A/S · Titan Touch Narrow Base Scrotal Zero Angle 18cm · 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 Titan Touch hydraulic penile implant is used for erectile dysfunction. Its 105 reports often describe pump tubing fractures, fluid leaks, and implants that were removed and replaced after surgery, along with wound openings and infections. There were no deaths and 99 injuries. 1 open recall, started in March 2023, concerns a thinner pump wall that could cause earlier pump failure.
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
- 105
- Deaths reported
- 0
- Injuries reported
- 99
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 05708932072564), received between Sep 6, 2018 and May 21, 2026 — classified as 99 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (27 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-1364-2023 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem35
- Fluid/Blood Leak27
- Fracture7
- Insufficient Device Problem Information7
- Inadequacy of Device Shape and/or Size5
- Malposition of Device5
- Inflation Problem4
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- Unspecified Infection26
- Bacterial Infection4
- Perforation3
- Erosion2
- Pain2
- Wound Dehiscence2
- Discomfort1
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING FRACTURE FROM PUMP TO CYLINDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241849 ↗InjuryMay 19, 2026Material Puncture/Hole; Device Damaged by Another Device
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED WITH A GENESIS DUE TO THE CYLINDER BEING PUNCTURED IN PREVIOUS SURGERY DURING CLOSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216472 ↗InjuryMar 25, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT (PUMP) WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING. THE PUMP WAS PLACED TOO SHORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689199 ↗InjuryFeb 23, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE PUMP WAS REMOVED AND REPLACED DUE TO A PUMP TUBING FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24418075 ↗InjuryFeb 9, 2026Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO DEVICE NOT FULLY INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24295446 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THE PATIENT HAD A HOLE IN THEIR SCROTUM [WOUND DEHISCENCE] AFTER THE SURGERY.
Patient problems: Wound Dehiscence
MAUDE report 24259093 ↗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 18CM NARROW CYLINDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905871 ↗InjuryDec 2, 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 IMPENDING EROSION ON THE RIGHT SIDE. THE LEFT SIDE WAS RETAINED AND ONLY THE RIGHT SIDE WAS REPLACED, WITH A NEW PUMP.
Patient problems: Erosion
MAUDE report 23696882 ↗MalfunctionSep 23, 2025Material Deformation; Material Deformation
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS AN ANEURYSM ON BOTH NARROW CYLINDERS. DEVICE WAS TESTED TO INFLATE, AND IT STARTED AFTER MILD MODELING. ISSUE HAPPENED DURING IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23121836 ↗InjuryAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22792890 ↗InjuryAug 12, 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 GENESIS AS A PLACEHOLDER DUE TO INFECTION. THE PLACEHOLDER WAS REMOVED, AND AN INFLATABLE PENILE PROSTHESIS WAS IMPLANTED AGAIN IN (B)(6) 2025.
Patient problems: Unspecified Infection
MAUDE report 22786693 ↗InjuryJul 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE PUMP FREEZING UP. UPON EXPLANT, THE PUMP WAS NOTED TO BE WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554249 ↗MalfunctionJul 11, 2025Material Deformation; Material Deformation
ACCORDING TO THE AVAILABLE INFORMATION, DURING IMPLANTATION THERE WAS AN ANEURYSM ON BOTH NARROW CYLINDERS ON TEST INFLATION. IT STARTED AFTER MILD MODELING. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22485185 ↗InjuryJun 23, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A PIN HOLE IN THE DISTAL CYLINDER. THE RESERVOIR REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306885 ↗InjuryJun 19, 2025Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE PUMP SITTING TOO POSTERIOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294134 ↗MalfunctionApr 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, A NARROW 18CM REQUIRED STACKING REAR TIP EXTENDERS [RTES] 3CM + 1CM BECAUSE THE PATIENT MEASURED 22CM. DUE TO THE USAGE OF 4CM OF RTES, THE DOCTOR NEEDED TO CUT THE PUMP OFF AND RECONNECT BECAUSE THERE WAS TOO MUCH TUBING. THERE WERE NO ISSUES WITH THE PATIENT OR THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901190 ↗MalfunctionMar 20, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR USED A NARROW 18CM AND HAD TO STACK 3CM PLUS 1CM BECAUSE THE PATIENT MEASURED 22CM. BECAUSE THE DOCTOR USED 4CM OF RTE, HE NEEDED TO CUT THE PUMP OFF AND RECONNECT BECAUSE THERE WAS TOO MUCH TUBING. THERE WAS NO ISSUE WITH THE PATIENT OR THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652210 ↗MalfunctionMar 5, 2025Failure to Pump; Failure to Pump
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT STATED THAT HIS PUMP STOPPED WORKING SOMETIME IN (B)(6) 2024. PATIENT IS SCHEDULED TO SEE A NEW UROLOGIST TO HAVE IT REPLACED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21526185 ↗InjuryJan 15, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THERE WAS A TUBING FRACTURE FROM THE CYLINDER TO THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21162324 ↗InjuryJan 7, 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 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21094170 ↗InjuryDec 11, 2024Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO CROSSOVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904837 ↗InjuryNov 25, 2024Inadequacy of Device Shape and/or Size; Deformation Due to Compressive Stress; Inadequacy of Device Shape and/or Size; Deformation Due to Compressive Stress
ACCORDING TO THE AVAILABLE INFORMATION, A REVISION WAS PERFORMED TO ADJUST THE PUMP AND SHORTEN THE TUBING ON ONE SIDE AS THE TUBING HAD GOTTEN KINKED. NOTHING WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20771460 ↗InjuryOct 30, 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 DUE TO EROSION ON AN UNKNOWN DATE AND LATER REPLACED.
Patient problems: Erosion
MAUDE report 20567422 ↗InjuryOct 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514322 ↗InjuryOct 7, 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 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20391200 ↗
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-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; 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
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; 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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