Titan ESR918Recalls & reported problems
Coloplast A/S · Scrotal OTR Zero Degree Angle Cylinder Set with Pump · Class 3 · Implant
Quick summary
This Coloplast Titan ESR918 is an implantable scrotal cylinder set with a pump, used to treat impotence. Most of the 72 reports describe the tubing or pump breaking, leaking fluid, or failing to inflate, and several mention the implant being removed and replaced or the surrounding tissue eroding. The reports list 65 injuries and no deaths. There are no recalls naming 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
- 72
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 05708932487665), received between Jul 23, 2017 and Apr 9, 2026 — classified as 65 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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
- Fracture15
- Break9
- Fluid/Blood Leak9
- Leak/Splash8
- Inflation Problem6
- Insufficient Device Problem Information6
- Inadequacy of Device Shape and/or Size4
- Mechanical Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Information18
- Erosion4
- Failure of Implant4
- No Code Available4
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Discomfort1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT REMOVED AND REPLACED WITH TITAN OTR DUE TO A TUBING BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834778 ↗InjuryDec 31, 2025Self-Activation or Keying; Self-Activation or Keying
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AUTO INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936815 ↗InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, A RIGHT CORPOROPLASTY WAS PERFORMED DUE TO EROSION. THE DEVICE WAS NOT EXPLANTED.
Patient problems: Erosion
MAUDE report 23881808 ↗InjuryAug 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903341 ↗InjuryJun 10, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A BREAK IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22180252 ↗InjuryFeb 13, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE DEVICE NO LONGER INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374792 ↗InjuryDec 31, 2024Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO A TUBING BREAK AT THE PUMP AND REPLACED BY A MALLEABLE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047429 ↗InjuryOct 17, 2024Pumping Problem; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE DEVICE WAS NOT PUMPING UP AND THE AGE OF THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20471083 ↗InjuryOct 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO UNKNOWN REASONING. REMOVAL OF DEVICE AND REPLACEMENT DEVICE INFORMATION WAS NOT REPORTED TO COLOPLAST AT THE TIME OF OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412206 ↗InjuryJul 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAK IN THE TUBING NEAR THE PUMP. PATIENT WANTED A NEW DEVICE AFTER TEN YEARS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680061 ↗InjuryMay 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372593 ↗InjuryApr 22, 2024Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED DUE TO FAILURE TO INFLATE THE CYLINDERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159662 ↗InjuryFeb 16, 2024Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING BREAK AT THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725854 ↗InjuryDec 7, 2023Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO BROKEN TUBING RIGHT WHERE THE CYLINDER AND PUMP CONNECT, WHERE THE PUMP GETS THICKER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18284137 ↗InjuryNov 29, 2023Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE NEAR THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18234415 ↗InjuryNov 29, 2023Material Erosion; Material Erosion
ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS EROSION NOTED ON THE RESERVOIR TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18229772 ↗InjuryNov 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT FAILED TO INFLATE AND CAUSE SWELLING IN THE SCROTUM. THE IMPLANT WAS EXPLANTED AND REPLACED AND WHEN PERFORMED DAMAGE WAS FOUND NEAR THE PUMP.
Patient problems: Swelling/ Edema
MAUDE report 18185058 ↗InjuryNov 15, 2023Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION IT WAS REPORTED BY OUR DISTRIBUTOR PARTNER ENDOCTOR THAT A 78 YEAR OLD PATIENT WHO HAD THE PROSTHESIS IMPANTED ON (B)(6) 2014 SOUGHT OUT HIS DOCTOR ON (B)(6) 2023 REPORTING THAT HE COULD NO LONGER INFLATE THE PROSTHESIS. THE PATIENT UNDERWENT AN MRI EXAM THROUGH WHICH THE DOCTOR FOUND THAT THERE WAS NO MORE LIQUID IN ANY PART OF THE SYSTEM, REQUIRING REVISION OF THE IMPLANT.THE PATIENT THEN UNDERWENT SURGERY ON (B)(6) 2023, WHEN THE DOCTOR REMOVED ALL COMPONENTS OF THE IMPLANT, RECONSTRUCTED THE PENILE CORPORA CAVERNOSA AND IMPLANTED A NEW COMPLETE PROSTHESIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144160 ↗InjuryNov 14, 2023Fracture; Fracture
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 18134284 ↗InjuryJun 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO AN UNSPECIFIED MALFUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078449 ↗InjuryMay 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO AN UNKNOWN REASON. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17023894 ↗InjuryMay 9, 2023Migration; Migration
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO MIGRATION. THE RESERVOIR MIGRATED DOWN FROM ITS ORIGINAL SPOT INTO THE INGUINAL CANAL AND THE DEVICE WAS GIVING THE PATIENT DISCOMFORT. THE DEVICE WAS OVER 10 YEARS OLD AND THE PATIENT WANTED A REPLACEMENT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Discomfort
MAUDE report 16896524 ↗InjuryApr 17, 2023Failure to Pump; Failure to Pump
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO NOT PUMPING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755943 ↗InjuryApr 11, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. ONLY THE PUMP WAS REPLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16718983 ↗InjuryMar 28, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A HOLE IN THE TUBING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625301 ↗
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-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Z-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; 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-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; 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-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.