Titan ER8125Recalls & reported problems
Coloplast A/S · CL Reservoir · Class 3 · Implant
Quick summary
This Coloplast Titan reservoir, a fluid-filled implant used for erectile dysfunction, has 169 reports, with no deaths and 149 injuries. Many reports describe the reservoir moving out of place, leaking fluid, constant self-inflation, and tubing breaks. Many injury reports say the implant was removed and replaced, and some mention a hernia. No recalls name this device, and reports rose from 27 in the prior 12 months to 40 in the latest 12 months.
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
- 166
- Deaths reported
- 0
- Injuries reported
- 146
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 05708932473927), received between Aug 23, 2017 and Jun 29, 2026 — classified as 146 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Migration” (52 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
- Migration52
- Migration or Expulsion of Device16
- Malposition of Device14
- Fluid/Blood Leak13
- Inflation Problem13
- Insufficient Device Problem Information11
- Adverse Event Without Identified Device or Use Problem8
- Self-Activation or Keying8
Patient problems
- No Clinical Signs, Symptoms or Conditions107
- No Information17
- Pain8
- Hernia7
- No Consequences Or Impact To Patient6
- Unspecified Infection5
- Discomfort4
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR REMOVED AND REPLACED DUE TO IT BEING PLACED INCORRECTLY SURGICALLY [MALPOSITION].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659953 ↗InjuryJun 16, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR REMOVED AND REPLACED DUE TO THE LOCATION NEEDING REVISION. RESERVOIR WORKED AS DESIGNED, HOWEVER, BECAME HERNIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524614 ↗InjuryJun 15, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR REMOVED AND REPLACED DUE TO A RESERVOIR HERNIATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25501547 ↗InjuryJun 9, 2026Short Fill
ACCORDING TO THE AVAILABLE INFORMATION, 80 CC WAS ADDED TO RESERVOIR FOR AN UNSPECIFIED REASON [UNDERFILL]. REPORTEDLY, THERE WAS NO LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443647 ↗InjuryJun 8, 2026Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE RESERVOIR BEING UNABLE TO KEEP FLUID [LEAK].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436829 ↗InjuryJun 2, 2026Material Puncture/Hole; Device Damaged by Another Device
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS PUNCTURED BY RADIOLOGIST. THE IMPLANT WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365996 ↗InjuryMay 11, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, A REVISION PROCEDURE WAS PERFORMED TO MOVE THE IMPLANTED RESERVOIR DUE TO MIGRATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137315 ↗InjuryMay 5, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR REMOVED AND REPLACED DUE TO MIGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087818 ↗InjuryMay 5, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR REMOVED AND REPLACED DUE TO A RESERVOIR HERNIATION [MIGRATION].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25081766 ↗InjuryMay 1, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS REPLACED DUE TO TEAR [FRACTURE] IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056273 ↗InjuryApr 24, 2026Filling Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WOULD NO LONGER INFLATE [REFILL] DUE TO SCARRING DOWN ENCAPSULATION. THE RESERVOIR WAS MOVED TO A NEW SPACE, THE DEVICE WAS NOT CHANGED OUT.
Patient problems: Scar Tissue
MAUDE report 24984061 ↗InjuryApr 22, 2026Material Puncture/Hole; Device Damaged by Another Device
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A RESERVOIR PUNCTURE DURING NEEDLE ASPIRATION OF ABSCESS IN ER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960283 ↗InjuryApr 22, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANTED RESERVOIR WAS REMOVED AND REPLACED DUE TO DISPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955161 ↗InjuryApr 17, 2026Short Fill
ACCORDING TO THE AVAILABLE INFORMATION, A REVISION PROCEDURE WAS PERFORMED TO ADD 120CC TO RESERVOIR. THERE WAS NO EXPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916309 ↗InjuryApr 16, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANTED RESERVOIR WAS PLACED INCORRECTLY AND WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904920 ↗InjuryApr 16, 2026Self-Activation or Keying
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT PUMP AND RESERVOIR WERE REMOVED AND REPLACED WITH TOUCH RESERVOIR AND TOUCH PUMP DUE TO AUTO INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896445 ↗InjuryApr 16, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE RESERVOIR BEING IN THE WRONG LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895086 ↗InjuryApr 14, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION THE RESERVOIR WAS REPOSITIONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874636 ↗InjuryApr 7, 2026Self-Activation or Keying; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED AS THE PHYSICIAN PUT THE RESERVOIR IN BACKWARDS, WHICH CAUSED THE PUMP TO FAIL AND AUTO INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799975 ↗InjuryApr 3, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS REMOVED AND REPLACED FOR AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781925 ↗InjuryApr 3, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS REMOVED AND REPLACED DUE TO IT BEING IN THE WRONG LOCATION. IT WAS NOTED THAT THE DEVICE NOT DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779062 ↗InjuryApr 3, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT MIGRATED OUT OF LEFT RETROPUBIC SPACE. IMPLANT RESERVOIR WAS REPOSITIONED. DEVICE STILL FUNCTIONAL AND REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777975 ↗InjuryMar 30, 2026Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT RESERVOIR WAS RELOCATED DUE TO EXTRUSION.
Patient problems: Erosion
MAUDE report 24735907 ↗InjuryMar 25, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT PUMP AND RESERVOIR WERE REPLACED AS THE RESERVOIR WAS OUT OF POSITION AND THE PUMP WAS TOO HIGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687107 ↗InjuryMar 20, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT DEVELOPED A BLISTER ON THE ABDOMEN OUTSIDE THE RESERVOIR, WHICH ENDED UP BECOMING AN INFECTION. PATIENT HAD THE DEVICE REMOVED. ADDITIONALLY, THE PATIENT MENTIONED THE CYLINDER HAD MOVED DOWN THREE INCHES. HIS UROLOGIST WAS ON VACATION AND WANTED HIM TO WAIT AND SEE IF THE INFECTION WOULD CLEAR AND PRESCRIBED ANTIBIOTICS. HE ENDED UP CONTACTING TWO OTHER UROLOGISTS. ONE TOLD HIM TO HAVE THE DEVICE REMOVED WHILE THE OTHER INFORMED HIM TO THE ER. THE PATIENT ALSO REPORTS THAT HE HAS BEEN IN PAIN FOR THE PAST FIVE YEARS.
Patient problems: Blister; Pain; Unspecified Infection
MAUDE report 24654007 ↗
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-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-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-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-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-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-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-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; 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.