Titan ESR920Recalls & reported problems
Coloplast A/S · Scrotal OTR 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 ESR920 scrotal cylinder implant set is a penile prosthesis used for impotence. The 76 reports mostly describe the implant's tubing cracking, fracturing or breaking, and fluid leaking out, sometimes with erosion of surrounding tissue; 70 reports involved injuries and no deaths. In many cases the implant was removed and replaced because of the broken tubing. 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
- 76
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 05708932487689), received between Jul 19, 2017 and Jun 26, 2026 — classified as 70 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (18 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
- Fracture18
- Break12
- Fluid/Blood Leak12
- Leak/Splash9
- Insufficient Device Problem Information6
- Inflation Problem4
- Adverse Event Without Identified Device or Use Problem3
- Material Erosion3
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Information25
- No Known Impact Or Consequence To Patient5
- Erosion3
- No Code Available3
- No Consequences Or Impact To Patient3
- Unspecified Infection2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25635594 ↗InjuryMar 25, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN OTR IMPLANT WAS REMOVED AND REPLACED DUE TO LOSS OF FLUID IN IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689525 ↗InjuryFeb 2, 2026Fluid/Blood Leak; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO BROKEN TUBING MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24233592 ↗InjuryDec 23, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE TUBING CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879791 ↗InjurySep 3, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951606 ↗InjuryAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO LOSS OF FLUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22733015 ↗InjuryApr 3, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO LOSS OF FLUID DUE TO TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762296 ↗InjuryFeb 20, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION IN THE CLEAR TUBING OF THE PROSTHETIC, WHICH IS ASSUMED TO BE A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422009 ↗InjuryFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413950 ↗InjuryOct 7, 2024Fracture; 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 20384543 ↗InjuryAug 26, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE IMPLANT WAS NOT FULLY INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20066203 ↗InjuryAug 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN OTR IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19942736 ↗InjuryApr 1, 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 AND REPLACED DUE TO EROSION/EXTRUSION.
Patient problems: Erosion
MAUDE report 19013039 ↗InjuryNov 28, 2023Break; Break
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18218338 ↗InjuryNov 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAK IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18174159 ↗InjuryNov 16, 2023Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NO LONGER BEING ABLE TO INFLATE THE PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18153933 ↗InjuryNov 13, 2023Fluid/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 18124896 ↗InjuryNov 9, 2023Material Erosion; Material Erosion
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO TUBE EROSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18101139 ↗InjuryJun 2, 2023Inflation Problem; Inflation Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO NOT INFLATING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056584 ↗InjuryMay 1, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING FRACTURE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16844964 ↗InjuryApr 19, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING FRACTURE. THE FRACTURE WAS FROM THE PUMP TO THE CYLINDERS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16772560 ↗InjuryApr 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO AN UNKNOWN REASON. A MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760840 ↗InjuryFeb 24, 2023Pumping Problem; Appropriate Device Problem Term/Code Not Available; Pumping Problem; Appropriate Device Problem Term/Code Not Available
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO PATIENT PREFERENCE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16440510 ↗InjuryFeb 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO FLUID LOSS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16353431 ↗InjuryJan 27, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING FRACTURE. THE FRACTURE WAS AT THE PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16253549 ↗
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-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; 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-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- 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-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- 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-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; 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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