Titan E17926Recalls & reported problems
Coloplast A/S · Cylinder Set - zero angle · Class 3 · Implant
Quick summary
This Coloplast Titan cylinder set is an implanted penile prosthesis component used for erectile dysfunction. The 43 reports mostly describe the cylinders breaking, shifting out of position, or being the wrong length, plus infections and erosion of surrounding tissue, with several implants removed or replaced. No deaths were reported, but 40 injuries and 3 malfunctions were. There are no recalls naming this device, and the report count is steady (9 in the last 12 months versus 8 before that).
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
- 42
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05708932487443), received between Jun 11, 2018 and Jun 23, 2026 — classified as 39 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 Problem13
- Fracture8
- Inadequacy of Device Shape and/or Size5
- Insufficient Device Problem Information4
- Pumping Problem3
- Appropriate Device Problem Term/Code Not Available2
- Migration2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Unspecified Infection8
- Erosion7
- No Information2
- Pain2
- Bacterial Infection1
- Fibrosis1
- Hematoma1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, A REVISION PROCEDURE IS SCHEDULED TO REPOSITION CYLINDER TIPS FOR IMMINENT EROSION. ACCORDING TO ADDITIONAL INFORMATION RECEIVED ON 23-JUN-2026: OVER THE PAST 10 YEARS, THE PATIENT'S RIGHT DISTAL CORPORA HAD BECOME WEAKENED LATERALLY [EROSION]. ON (B)(6) 2026, THE RIGHT TIP WAS RE-TUNNELLED MEDIALLY AND A KEITH NEEDLE WAS USED TO REINTRODUCE THE DISTAL TIP MID GLANS. THE ORIGINAL DEVICE WAS KEPT INSITU. THERE WAS NO DEVICE MALFUNCTION.
Patient problems: Erosion
MAUDE report 25599816 ↗InjuryJun 11, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO INCORRECT SIZING (TOO SHORT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476709 ↗InjuryJun 8, 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 AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25436689 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANTED CYLINDERS WERE SWAPPED OUT DUE TO NEAR EROSION.
Patient problems: Erosion
MAUDE report 25055958 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, TITAN IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24896665 ↗InjuryApr 15, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885512 ↗InjuryMar 30, 2026Inadequacy of Device Shape and/or Size; Migration
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO CYLINDER MIGRATION AND DID NOT REACH GLANDS. REPLACED 26CM WITH 28CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728115 ↗InjuryNov 7, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE PUMP WAS EXPLANTED AND REPLACED DUE TO BROKEN TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496602 ↗InjuryAug 13, 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 WITH A MALLEABLE DUE TO INFECTION. IT WAS NOTED THERE WAS PUS.
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 22793222 ↗InjuryAug 6, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A HOLE IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22726237 ↗InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, IT WAS REPORTED THAT THE PATIENT USED THEIR INFLATABLE PENILE PROSTHESIS EIGHT DAYS POST IMPLANT AND GOT AN INFECTION. THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE AS A PLACEHOLDER. THE PLACEHOLDER WAS RECENTLY REMOVED AND REPLACED WITH ANOTHER INFLATABLE IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 22719556 ↗InjuryAug 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, THE LEFT CYLINDER EXTRUDED OUT OF AN OPEN HEALED CORPOROTOMY. THE CYLINDER WAS EXPLANTED AND REPLACED.
Patient problems: Erosion
MAUDE report 22719027 ↗InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, WITHIN TWENTY-FOUR HOURS OF THE SURGERY, THE PATIENT HAD EROSION. THE DEVICE WAS REMOVED.
Patient problems: Erosion
MAUDE report 22122403 ↗InjuryMay 9, 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 PENDING EROSION AND PAIN.
Patient problems: Erosion; Pain
MAUDE report 21997184 ↗InjuryMar 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE IMPLANT NOT BEING FIRM ENOUGH. IT WAS NOT KNOWN IF THIS WAS PATIENT PREFERENCE OR RELATED TO A DEVICE ISSUE (UNDERFILL, LEAK ETC).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21621567 ↗InjuryFeb 19, 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 EROSION AND INFECTION.
Patient problems: Erosion; Unspecified Infection
MAUDE report 21411744 ↗InjuryAug 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20070517 ↗InjuryJun 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A SIZING ISSUE. THE LEFT CYLINDER WAS REPLACED WITH A SHORTER CYLINDER (26CM TO 24CM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19481341 ↗InjuryJun 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO THE CYLINDER BEING TOO LONG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19477250 ↗InjuryDec 13, 2023Adverse 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 INFECTION AND EROSION.
Patient problems: Erosion; Unspecified Infection
MAUDE report 18319216 ↗InjuryDec 12, 2023Break; Break
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18312406 ↗InjuryFeb 21, 2023Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A HOLE IN A CYLINDER. THERE WAS A HOLE IN THE LEFT CYLINDER AT THE KNUCKLE SITE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16415219 ↗InjuryDec 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A MALFUNCTION. THE RESERVOIR WAS RETAINED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16045092 ↗InjuryDec 15, 2022Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING FRACTURE. THE FRACTURE WAS FROM THE PUMP TO THE CYLINDER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15986424 ↗InjurySep 24, 2022Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15476643 ↗
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-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-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; 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-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-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.