Titan 517750Recalls & reported problems
Coloplast A/S · Titan Touch Pump · 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 Coloplast Titan Touch pump is the pump in an inflatable penile implant. Reports most often describe tubing fractures, pumps not working, fluid leaks and inflation problems, and some mention infections or erosion. There are 259 reports, with no deaths and 239 injuries. Reports fell to 16 in the last 12 months from 44 in the year before. 1 recall is open, begun in March 2023, over pump walls thinner than standard, which could lead to 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
- 258
- Deaths reported
- 0
- Injuries reported
- 238
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 05708932533966), received between Jul 24, 2017 and May 19, 2026 — classified as 238 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (60 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-1359-2023 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture60
- Adverse Event Without Identified Device or Use Problem35
- Insufficient Device Problem Information26
- Pumping Problem25
- Fluid/Blood Leak22
- Inflation Problem21
- Inadequacy of Device Shape and/or Size16
- Break11
Patient problems
- No Clinical Signs, Symptoms or Conditions157
- Unspecified Infection36
- No Information29
- Erosion12
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient5
- Pain5
- Failure of Implant4
Recent adverse event reports
The 25 most recent of 258 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING BREAK AT THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25218438 ↗InjuryMay 6, 2026Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE PUMP NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25094571 ↗InjuryApr 7, 2026Patient-Device Incompatibility
ACCORDING TO THE AVAILABLE INFORMATION THE PUMP AND RESERVOIR WERE REPLACED DUE TO PATIENT PREFERENCE. PATIENT HAS ARTHRITIS CANNOT USE THE TOUCH ANYMORE AND REQUESTED A CLASSIC [DEXTERITY ISSUE].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799839 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO EROSION.
Patient problems: Erosion
MAUDE report 24651211 ↗InjuryFeb 17, 2026Inadequacy of Device Shape and/or Size; Migration
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PATIENT COULDN'T REACH DEFLATE BUTTON. SURGEON ADDED EXTRA LENGTH TO TUBING TO SIT LOWER IN SCROTUM. POSSIBLE PUMP MIGRATION SUPERIORLY OVER 3 MONTHS OF USE. PUMP WAS TOO HIGH IN THE SCROTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24367046 ↗InjuryFeb 4, 2026Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO A VALVE ISSUE. THE PRODUCT WOULD NOT INFLATE PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261958 ↗InjuryJan 19, 2026Material Separation
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A COMPLETE SEPARATION OF THE PUMP AND RELEASE BAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111438 ↗InjuryJan 16, 2026Inadequacy of Device Shape and/or Size; Deformation Due to Compressive Stress
ACCORDING TO THE AVAILABLE INFORMATION THE DOCTOR DID SCROTAL EXPLORATORY SURGERY TO ASSESS WHY THE PATIENT SAID THE IMPLANT WAS NOT WORKING. THERE WAS A LOT OF EXTRA TUBING VISIBLE THROUGH THE SCROTAL SKIN PREOPERATIVELY. THE DOCTOR FELT THE TUBING WAS GETTING KINKED WHEN THE PATIENT PUMPED IT. THE PUMP WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094303 ↗InjuryDec 31, 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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23937353 ↗InjuryDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED & REPLACED DUE TO THE DEVICE NOT WORKING ANY LONGER. THE DEVICE WAS NOTED TO BE OLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872368 ↗InjuryDec 19, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED & REPLACED DUE TO A BREAK IN THE CYLINDER TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854845 ↗InjuryDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO LACK OF FLUID IN SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828141 ↗InjuryDec 8, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION. THERE WAS A BREAK IN THE TUBING, SO THE PUMP AND THE CYLINDERS WERE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746858 ↗MalfunctionDec 2, 2025Failure to Pump; Failure to Pump
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT STATED THAT WITHIN THE LAST 6 MONTHS HE HAS NOT BEEN ABLE TO PUMP THE IMPLANT AT ALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693982 ↗InjuryNov 19, 2025Material Frayed; Material Frayed
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO FRAYED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593654 ↗InjurySep 18, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO IT BEING HARD FOR THE PATIENT TO CYCLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23083534 ↗InjuryAug 27, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED AS IT WAS NOT FULLY INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904759 ↗InjuryAug 18, 2025Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO THE PATIENT HAVING HEMATOMA CAUSING HIS PUMP TO BE MISPLACED.
Patient problems: Hematoma
MAUDE report 22828066 ↗InjuryJul 23, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE DEVICE NOT FULLY INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580216 ↗InjuryJul 7, 2025Unintended Deflation; Unintended Deflation
ACCORDING TO THE AVAILABLE INFORMATION THE PUMP AND RESERVOIR WERE EXPLANTED AND REPLACED DUE TO THE DEVICE DEFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411649 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS EXPLANTED AND REPLACED AT A LATER DATE DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22331739 ↗InjuryJun 18, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE FROM THE PUMP TO THE CYLINDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22283253 ↗InjuryJun 13, 2025Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, A REVISION SURGERY WAS PERFORMED TO REPOSITION THE RIGHT CYLINDER. THE PHYSICIAN ALSO REMOVED 1CM REAR TIP ON RIGHT AND CHOPPED OFF A CM AS THE DEVICE FELT TOO LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22204143 ↗InjuryJun 3, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO LEFT SIDE TUBING FRACTURE FROM THE PUMP TO THE CYLINDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136989 ↗InjuryMay 28, 2025Inflation Problem; Failure to Pump; Failure to Deflate; Inflation Problem; Failure to Pump; Failure to Deflate
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED AS THE CYLINDERS WERE NOT INFLATING AND DEFLATING DUE TO A PUMP MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22100622 ↗
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-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; 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-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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 ES8918Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall225 reports
- Titan ES2818Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall222 reports
- Titan ES8820Coloplast A/S · Device, Impotence, Mechanical/Hydraulic1 recall192 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.
How reports and recalls are matched · Editorial policy · Report an error on this page