Titan EN2914Recalls & reported problems
Coloplast A/S · Titan® Touch Scrotal Zero Degree Angle Cylinder Set with Pump - Narrow · Class 3 · Implant
Quick summary
This Titan EN2914 is a Coloplast inflatable penile implant set used to treat impotence. The 37 reports mostly describe leaking or broken tubing, parts cracking or failing to inflate properly, and sizing that did not work, often leading to infection or the need to remove and replace the implant. There were35 injuries and no deaths. 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
- 37
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05708932539098), received between Jul 23, 2017 and Jun 11, 2026 — classified as 35 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Fluid/Blood Leak8
- Insufficient Device Problem Information5
- Fracture4
- Inadequacy of Device Shape and/or Size3
- Inflation Problem2
- Migration2
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Unspecified Infection9
- No Information4
- Bacterial Infection1
- Erosion1
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25472794 ↗InjurySep 11, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A RIGHT-SIDE CYLINDER TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030519 ↗InjuryJun 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A STICKY PUMP. THE RESERVOIR WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346360 ↗MalfunctionMay 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, DURING A VIRGIN IMPLANT, THE PATIENT WAS MEASURED FOR A 14 CM DEVICE. HOWEVER, THE PHYSICIAN WAS NOT ABLE TO GET THE IMPLANT IN. IT WAS THEN DECIDED TO DOWNSIDE THE PATIENT TO AN 11 CM IMPLANT WITH 2CM REAR TIP EXTENDERS ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004251 ↗InjuryNov 5, 2024Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613636 ↗InjuryJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19561778 ↗InjuryJun 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536693 ↗InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19505052 ↗InjuryMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392674 ↗InjuryMay 22, 2024Inadequacy 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 DEVICE WAS REMOVED AND REPLACED DUE TO A SIZING ISSUE. THE PUMP WAS RIDING UP AND THE REAR TIPS WENT FROM NARROW 14CM TIPS TO 18CM REAR TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372375 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19300184 ↗InjuryApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19215891 ↗InjuryApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213887 ↗InjuryApr 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE HAD A TUBING LEAKAGE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19136278 ↗InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19034369 ↗MalfunctionMar 20, 2024Air/Gas in Device; Air/Gas in Device
ACCORDING TO THE AVAILABLE INFORMATION, DURING PREP, THE CYLINDERS WOULD KEEP ALLOWING AIR IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18944199 ↗InjuryFeb 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18663760 ↗InjuryJan 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO A TUBING LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18525972 ↗InjuryJan 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED DUE TO A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489535 ↗InjuryJan 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489398 ↗InjuryDec 26, 2023Migration; Migration
ACCORDING TO THE AVAILABLE THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE PUMP PLACEMENT BEING TOO HIGH IN THE SCROTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18393106 ↗InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED WITH A GENESIS DEVICE DUE TO AN INFECTION IN HIS LEFT SCROTUM.
Patient problems: Unspecified Infection
MAUDE report 18279283 ↗InjuryNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18231191 ↗InjuryNov 16, 2023Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION FROM OUR DISTRIBUTOR PARTNER ENDOCTOR THAT A PATIENT 57YEARS OLD, HAD PROSTHESIS IMPLANTED ON (B)(6) 2019, SOUGHT THE DOCTOR ON (B)(6) 2022 REPORTING THAT THE PROSTHESIS PARTIALLY INFLATED, MAKING IT IMPOSSIBLE TO ACHIEVE SUFFICIENT ERECTION TO MAINTAIN SEXUAL INTERCOURSE. HE UNDERWENT AN ULTRASOUND EXAMINATION WHICH FOUND, FLOW IN RIGHT DORSAL ARTERY, SIGNS OF DIFFUSE PEYRONIE'S DISEASE, CYLINDERS POSITIONED IN BOTH CORPORA CAVERNOSA, RESERVOIR ON THE LEFT PARTIALLY FULL 39 ML, RIGHT CYLINDER WITH SMALLER DIAMETER BASE (DOCTOR'S CHOICE WHEN IMPLANTING THE PROSTHESIS), DISTAL ASYMMETRIC CYLINDERS (DOCTOR'S CHOICE WHEN IMPLANTING THE PROSTHESIS), AXIAL STIFFNESS RATING: 4/10. THE PATIENT DOES NOT HAVE ADEQUATE AXIAL RIGIDITY AT THE BASE OF THE PENIS WITH INSTABILITY WHERE THE PENIS BENDS, LEAVING IT FUNCTIONALLY UNSUITABLE FOR THE ACT OF PENETRATION. THE PATIENT CHOSE TO REPLACE IT WITH ANOTHER COMPANY¿S PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18149811 ↗InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO INFECTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 15439419 ↗
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-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; 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-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; 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-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.