Titan ER8075Recalls & reported problems
Coloplast A/S · CL Reservoir · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Coloplast CL Reservoir is the implanted fluid reservoir used in a penile implant for impotence. Most of the 67 reports describe the reservoir shifting out of place or being pushed out of position, sometimes from weight loss, along with leaking fluid or blood, and pain or erosion where it sits; many also mention the reservoir filling or emptying on its own. 57 reports describe 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
- 66
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 05708932473910), received between Jul 19, 2017 and Jun 9, 2026 — classified as 56 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Migration” (10 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
- Migration10
- Insufficient Device Problem Information9
- Fluid/Blood Leak8
- Adverse Event Without Identified Device or Use Problem5
- Migration or Expulsion of Device4
- Self-Activation or Keying4
- Device Appears to Trigger Rejection3
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Information10
- Pain7
- Erosion4
- No Code Available2
- No Consequences Or Impact To Patient2
- Bacterial Infection1
- Capsular Contracture1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR REMOVED AND REPLACED DUE TO EXTRUSION.
Patient problems: Erosion
MAUDE report 25444959 ↗InjuryMay 5, 2026Migration
ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR REMOVED AND REPLACED DUE TO LARGE WEIGHT LOSS DISPLACING THE RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25082226 ↗InjuryApr 22, 2026Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT RESERVOIR WAS REMOVED AND REPLACED DUE TO UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957597 ↗InjuryFeb 26, 2026Self-Activation or Keying
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS REMOVED AND REPLACED DUE TO AUTO INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457534 ↗MalfunctionJan 14, 2026Material Separation
ACCORDING TO THE AVAILABLE INFORMATION, DURING REPLACEMENT OF THE DEVICE FOR AN ISSUE RELATED TO THE CYLINDER SET/ TUBING, A MALFUNCTION OF THE RESERVOIR WAS NOTED. THE GLUE SEEMINGLY FAILED. A PICTURE OF THE DEVICE SHOWS THE LOCKOUT VALVE SEPARATED FROM THE RESERVOIR BLADDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072242 ↗InjuryJan 6, 2026Unintended Deflation
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AUTO DEFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976084 ↗InjuryDec 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EXTRUSION.
Patient problems: Erosion
MAUDE report 23928857 ↗InjuryDec 17, 2025Migration; Migration
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A HERNIATED RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831472 ↗InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ACCORDING TO THE AVAILABLE INFORMATION THE RESERVOIR WAS EXPLANTED AND REPLACED DUE TO EXTRUSION. THE RESERVOIR WAS IN WORKING CONDITION, BUT POOR ANATOMICAL POSITION.
Patient problems: Erosion
MAUDE report 23406491 ↗InjurySep 15, 2025Self-Activation or Keying; Self-Activation or Keying
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS EXPLANTED AND REPLACED DUE TO AUTO INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058900 ↗InjurySep 12, 2025Disconnection; Disconnection
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS EXPLANTED AND REPLACED DUE TO THE RESERVOIR NOT BEING CONNECTED AT THE WHITE CONNECTION JUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039631 ↗InjurySep 10, 2025Migration; Migration
ACCORDING TO THE AVAILABLE INFORMATION THE PUMP AND RESERVOIR WERE EXPLANTED AND REPLACED DUE TO THE RESERVOIR MIGRATING INTO THE SCROTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23021032 ↗InjurySep 2, 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 22937662 ↗InjuryJun 23, 2025Migration; Migration
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS EXPLANTED AND REPLACED DUE TO IT MIGRATING FROM ITS ORIGINAL PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22311396 ↗InjuryMay 13, 2025Migration; Migration
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO RESERVOIR HERNIATION [MIGRATION].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013254 ↗MalfunctionMay 1, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE LABEL ON THE INNER PACKAGE OF THE KIT CLAIMS THAT THE DEVICE IS A '125 CC TITAN CL RESERVOIR', BUT THE DEVICE IS A 75 CC RESERVOIR. ALL OF THE LOT NUMBERS ON THE BOX, INNER PACKAGING, AND DEVICE MATCH AND REPRESENT A 75CC TITAN CL RESERVOIR DEVICE, BUT THE LABEL ON THE INNER PACKAGE INCORRECTLY STATES THAT IT IS THE LARGER TITAN RESERVOIR (125CC). THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941755 ↗InjuryMar 26, 2025Migration; Migration
ACCORDING TO THE AVAILABLE INFORMATION, DURING THIS REVISION, THE RESERVOIR WAS REPLACED AND REPOSITIONED AS IT HAD MIGRATED TOO LOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21700424 ↗MalfunctionFeb 20, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device
ACCORDING TO THE AVAILABLE INFORMATION, DURING PREP, ALL OF THE AIR DID NOT COME OUT OF THE RESERVOIR AND THE PHYSICIAN SUSPECTED THERE WAS A LEAK. THE RESERVOIR WAS NOT IMPLANTED AND A DIFFERENT 75 CC RESERVOIR WAS PLACED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21427341 ↗InjuryOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR WAS REMOVED AND REPLACED DUE TO A LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398658 ↗InjuryJul 22, 2024Adverse 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 LOWER ABDOMEN PAIN.
Patient problems: Pain
MAUDE report 19793721 ↗InjuryJul 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A RESERVOIR TUBING TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680755 ↗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 19562809 ↗MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, A LEAK IN THE RESERVOIR WAS FOUND DURING PRE-SURGICAL ASSEMBLY AND TESTING OF THE PROSTHESIS COMPONENTS. THE NURSE REPLACED THE RESERVOIR, AND THE SURGERY WAS CONTINUED WITHOUT COMPLICATIONS. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19311749 ↗InjuryMay 6, 2024Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, REVISION SURGERY WAS PERFORMED TO RE-POSITION THE SUBMUSCULAR RESERVOIR DEEPER AND REMOVE SOME OF THE FLUID (10-20ML) FROM THE RESERVOIR. THE TUBING WAS CUT AND RECONNECTED IN ORDER TO DO THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19248172 ↗InjuryApr 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO A TUBING LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213285 ↗
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-1373-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; 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-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; 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-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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