Titan ES2816Recalls & reported problems
Coloplast A/S · Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump · Class 3 · Implant
All models of Titan (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Coloplast Titan Touch penile implant has 94 reports, 84 of them injuries, and no deaths. Common reports describe tubing breaking, tearing, or leaking, the pump not inflating properly, infections, and implants being removed and replaced. No recalls name this device.
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
- 93
- Deaths reported
- 0
- Injuries reported
- 83
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 05708932539111), received between Jul 23, 2017 and Jun 23, 2026 — classified as 83 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).
18 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
Most reported problems
Device problems
- Fluid/Blood Leak14
- Adverse Event Without Identified Device or Use Problem11
- Inadequacy of Device Shape and/or Size11
- Inflation Problem11
- Insufficient Device Problem Information10
- Fracture9
- Pumping Problem7
- Leak/Splash6
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Information14
- Unspecified Infection12
- No Consequences Or Impact To Patient7
- Erosion3
- Bacterial Infection2
- Failure of Implant1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Inflation Problem; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE PUMP NOT WORKING CORRECTLY AND THE DEVICE NOT FULLY INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25597571 ↗InjuryJun 2, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A FRACTURE ON THE CYLINDER TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365806 ↗InjuryApr 28, 2026Material Puncture/Hole
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A HOLE IN THE PUMP TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017304 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO IMPENDING EROSION.
Patient problems: Erosion
MAUDE report 24779999 ↗InjuryJan 28, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED WITH A GENESIS DUE TO TUBING BREAK CONNECTING CYLINDER TO PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200945 ↗InjuryNov 21, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO RESERVOIR TUBING TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23618780 ↗InjuryNov 19, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INCORRECT SIZING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597247 ↗InjurySep 24, 2025Fluid/Blood Leak; Inadequacy of Device Shape and/or Size; Fluid/Blood Leak; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE CYLINDERS BEING TOO SHORT DURING THE IMPLANT SURGERY IN 2017 AND AS A RESULT NOW HAVING A LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23135686 ↗InjuryMay 22, 2025Fluid/Blood Leak; Failure to Pump; Fluid/Blood Leak; Failure to Pump
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED AS THE IMPLANT WAS NO LONGER PUMPING AND THERE WAS NO FLUID IN THE RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069407 ↗InjuryApr 24, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A BREAK IN THE TUBING FROM THE PUMP TO RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901496 ↗InjuryMar 26, 2025Pumping Problem; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT PUMP WAS REMOVED AND REPLACED DUE TO THE PUMP BEING FAULTY [PUMPING ISSUE].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21698582 ↗InjuryFeb 24, 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, THE IMPLANT WAS REMOVED AND REPLACED AS THE LEFT CYLINDER WAS FOLDED AND THE PATIENT WAS MAJORLY UNDERSIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21450537 ↗InjuryJan 15, 2025Device Appears to Trigger Rejection; Inadequacy of Device Shape and/or Size; Device Appears to Trigger Rejection; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INCORRECT SIZE AND EROSION/EXTRUSION OF THE IMPLANT.
Patient problems: Erosion
MAUDE report 21157827 ↗InjuryJan 7, 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, THE IMPLANT WAS REMOVED AND REPLACED AS THE IMPLANT WAS UNDERSIZED AND THERE WAS BAD PUMP PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21091650 ↗InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. A NEW DEVICE WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892278 ↗InjuryNov 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20640249 ↗InjuryOct 30, 2024Off-Label Use; Insufficient Device Problem Information; Migration; Off-Label Use; Insufficient Device Problem Information; Migration
ACCORDING TO ADDITIONAL INFORMATION FROM AN OPERATIVE REPORT THAT WAS RECEIVED ON 22-JAN-2025, THE PATIENT DEVELOPED APPENDICITIS. DURING APPENDECTOMY, IT BECAME CLEAR THAT HE HAD INTRA-ABDOMINAL LOCATION OF THE RESERVOIR [MIGRATION]. THE REVISION THAT OCCURRED WAS TO REMOVE THE POTENTIALLY CHRONICALLY INFECTED RESERVOIR AND PLACE A NEW RESERVOIR IN THE LEFT SUBMUSCULAR SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 20568986 ↗InjuryOct 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED AT A LATER DATE DUE TO AN UNKNOWN REASON. THE DETAILS REGARDING THE EXPLANT ARE NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398434 ↗InjuryJul 30, 2024Off-Label Use; Migration; Off-Label Use; Migration
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT'S PUMP MIGRATED AND WAS REVISED AND MULTIPLE SUTURES PLACED TO DISCOURAGE UPWARD MIGRATION.
Patient problems: Impaired Healing
MAUDE report 19861504 ↗InjuryJul 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19782378 ↗InjuryJul 10, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS UNABLE TO INFLATE. DURING THE REVISION, IT WAS FOUND THAT THERE WAS A HOLE IN THE RIGHT CYLINDER. NO OTHER PATIENT ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19712909 ↗InjuryJun 14, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE IMPLANT BEING UNDERSIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19542934 ↗InjuryApr 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION. ONLY THE CYLINDER SET WITH PUMP WAS A COLOPLAST PRODUCT, THE EXPLANTED RESERVOIR WAS AN AMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19115266 ↗InjuryJan 4, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO SIZE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18447979 ↗InjuryDec 26, 2023Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT REMOVED AND REPLACED DUE TO HOLE IN TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18393734 ↗
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-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
…and 3 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
- 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