Titan EN2814Recalls & reported problems
Coloplast A/S · Titan® Touch Infrapubic Zero Degree Angle Cylinder Set with Pump - Narrow · Class 3 · Implant
All models of Titan (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05708932539074), received between Oct 26, 2017 and Feb 20, 2024 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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
- Inadequacy of Device Shape and/or Size3
- Fracture2
- Pumping Problem2
- Connection Problem1
- Device Appears to Trigger Rejection1
- Fitting Problem1
- Inflation Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Information5
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 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 A SIZE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743381 ↗MalfunctionFeb 13, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT IS TOO SHORT FOR ADEQUATE INTERCOURSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18695640 ↗InjuryOct 14, 2022Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THE BREAK WAS IN THE TUBING BY THE CYLINDER. THE RESERVOIR WAS RETAINED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15606530 ↗InjuryJan 6, 2022Pumping Problem; Pumping Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS REPLACED DUE TO PATIENT FINDING IT HARD TO PUMP THE DEVICE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13181203 ↗InjuryMay 18, 2021Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED DUE TO A TUBING MALFUNCTION. A NEW DEVICE WAS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11841128 ↗InjuryOct 17, 2019Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION. FUNCTIONING IMPLANT EXTRUDED THROUGH PROXIMAL CORPORA.
Patient problems: No Information
MAUDE report 9204933 ↗InjuryAug 15, 2019Pumping Problem; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION:UNABLE TO PUMP.
Patient problems: No Information
MAUDE report 8898690 ↗InjuryMar 8, 2019Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS A LEAK AT THE PUMP BLACK TUBING.
Patient problems: No Information; Pain
MAUDE report 8405218 ↗InjuryNov 27, 2017Fitting Problem
ACCORDING TO THE AVAILABLE INFORMATION, 14CM TITAN TOUCH WAS EXPLANTED BECAUSE IT WAS TOO SHORT. PATIENT WAS REVISED WITH 20CM TITAN TOUCH.
Patient problems: No Information
MAUDE report 7061071 ↗InjuryNov 20, 2017Inflation Problem; Inadequacy of Device Shape and/or Size; Inflation Problem
ACCORDING TOT HE AVAILABLE INFORMATION, 14 CM TITAN TOUCH WAS EXPLANTED BECAUSE IT WAS TOO SHORT. PATIENT WAS REVISED WITH 20 CM TITAN TOUCH.
Patient problems: No Code Available; No Information
MAUDE report 7045373 ↗InjuryOct 26, 2017Connection Problem
ACCORDING TO THE AVAILABLE INFORMATION, TITAN TOUCH EN2814 WAS EXPLANTED APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION DUE TO CONNECTOR ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6980808 ↗
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-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- 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-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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.
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