Titan ESR820Recalls & reported problems
Coloplast A/S · Infrapubic 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 ESR820 is a hydraulic penile implant used to treat erectile dysfunction. There are 25 adverse event reports naming this device, with no deaths and 19 injuries. Reports mostly describe parts of the implant breaking or fracturing, tubing or reservoir leaks, and fluid loss, often leading to the device being removed and replaced; a few mention a cylinder that did not fit properly. No recalls name this device. Reports have slowed, with none filed in the most recent 12 months compared with 5 in the year before.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05708932487566), received between Oct 4, 2017 and Oct 8, 2025 — classified as 19 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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
- Fracture6
- Break4
- Adverse Event Without Identified Device or Use Problem3
- Fluid/Blood Leak3
- Insufficient Device Problem Information3
- Inadequacy of Device Shape and/or Size2
- Inflation Problem2
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Information4
- Failure of Implant3
- Erosion2
- No Consequences Or Impact To Patient2
- Unspecified Infection2
- Genital Bleeding1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED AS THE DEVICE HAD EXPERIENCED A MECHANICAL FAILURE AND HAD NO FLUID IN THE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23247785 ↗InjuryJun 20, 2025Fracture; 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 22301496 ↗InjuryMay 6, 2025Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION; THE IMPLANT WAS ALSO 10+ YEARS OLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971679 ↗InjuryJan 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED AT A LATER DATE WITH A MALLEABLE DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21198130 ↗InjuryNov 11, 2024Fluid/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 20658765 ↗InjuryNov 14, 2022Inflation Problem; Inflation Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO NO LONGER INFLATING. A MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15787858 ↗InjuryMar 11, 2022Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO A BREAK IN THE RESERVOIR TUBING BEFORE THE CONNECTOR. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13728438 ↗InjuryJan 5, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A CYLINDER THAT WAS TOO LONG. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172677 ↗InjuryDec 16, 2021Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13021368 ↗InjuryNov 7, 2021Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON (B)(6) 2014 AND REVISED ON (B)(6) 2021 DUE TO A TUBING FRACTURE BY THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12758766 ↗MalfunctionAug 5, 2021Inflation Problem; Inflation Problem
ACCORDING TO AVAILABLE INFORMATION, MALFUNCTION: WOULDN'T PUMP UP. DEVICE WAS THROWN AWAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12285415 ↗InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, A STUDY WAS PUBLISHED IN A MEDICAL JOURNAL. IT REPORTED THAT A PATIENT DEVELOPED A VOLUMINOUS HEMATOMA OF THE PENIS AND SCROTUM AFTER INFLATABLE PENILE PROSTHESIS (IPP) WITH DRAINAGE IN SUCTION. AFTER TEN HOURS AT NIGHT, THE VOLUME OF THE SCROTUM AND BASE OF THE PENIS BEGAN TO INCREASE. THE PATIENT WAS IMMEDIATELY CHECKED INTO THE OPERATING ROOM (OR); HOWEVER, OBVIOUS SOURCES OF BLEEDING FAILED TO BE IDENTIFIED. LOCAL AND SCROTAL WASHES WERE PERFORMED. CYLINDERS WERE KEPT INFLATED FOR TEN DAY. FOLLOWING SURGERY, THE PATIENT WAS DIAGNOSED WITH AN UNKNOWN COAGULATIVE DISEASE. ADDITIONALLY, THERE WAS DIFFICULTY DISCOVERED THE GLANS, WHICH PERSISTED FOR A MONTH,
Patient problems: Genital Bleeding
MAUDE report 11819725 ↗InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, URETHRAL EROSION AND INFECTION OCCURRED. CULTURES WERE TAKEN; HOWEVER, THE RESULTS WERE NOT PROVIDED AS OF THE DATE OF THIS REPORT.
Patient problems: Erosion; Unspecified Infection
MAUDE report 11791969 ↗MalfunctionFeb 8, 2021Fluid/Blood Leak; Pumping Problem; Fluid/Blood Leak; Pumping Problem
BASED ON THE AVAILABLE INFORMATION, THE REPORTED COMPLAINT IS IDENTIFIED IN THE RISK MANAGEMENT DOCUMENTATION AND REVIEWED ROUTINELY WITH MANAGEMENT TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 11292101 ↗MalfunctionJan 30, 2021Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, THIS WAS A REVISION OF A COLOPLAST OTR. THE IMPLANT BEING REMOVED HAD A TUBE FRACTURE JUST ABOVE THE PUMP. ALSO WHEN REMOVING DAMAGED IPP ONE OF THE REAR TIPS CAME OFF AND WAS STUCK IN THE RIGHT CORPORAL BODY. THE USE OF A FLEXIBLE CYSTOSCOPE WAS NEEDED TO LOCATE AND REMOVE. DEVICE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: THE HOSPITAL SAID THEY WILL RETURN IT, BUT THEY HAD A PROCESS TO FOLLOW FIRST. THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.
Patient problems: Failure of Implant
MAUDE report 11255602 ↗MalfunctionDec 17, 2020Break; Break
ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, PHYSICIAN REMOVED ALL OTR DEVICE (PUMP, CYLINDERS, AND RESERVOIR, RTES. REPLACED WITH NEW DEVICE. ADDITIONAL INFORMATION RECEIVED ON 11/25/2020: REVISION WAS DUE TO TUBING BREAK NEAR PUMP, AND FLUID LOSS. UNKNOWN IF DEVICE WILL BE RETURNED TO COLOPLAST.
Patient problems: Failure of Implant
MAUDE report 11033439 ↗MalfunctionNov 8, 2020No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, MALFUNCTION. DEVICE REMOVED AND REPLACED. ADDITIONAL INFO. FROM TM ON (B)(6) 2020, "THERE ALSO WAS NOT AN OBVIOUS REASON FOR THE MALFUNCTION THAT I RECALL." THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE, AND NO TRENDS WERE NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10806956 ↗MalfunctionJun 18, 2020Break; Break
ACCORDING TO THE AVAILABLE INFORMATION, CRACK IN CLEAR TUBING COMING FROM THE PUMP. DEVICE WAS REMOVED AND REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10169542 ↗InjuryJun 21, 2019Leak/Splash; Leak/Splash
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE LEAKED.
Patient problems: No Information
MAUDE report 8725232 ↗InjuryFeb 26, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion
ACCORDING TO THE AVAILABLE INFORMATION, EROSION/EXTRUSION. IMPENDING EROSION.
Patient problems: Erosion
MAUDE report 8371539 ↗InjuryApr 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, TITAN OTR WAS EXPLANTED DUE TO INCORRECT SIZING.
Patient problems: No Information
MAUDE report 7474211 ↗InjuryDec 11, 2017Device Operates Differently Than Expected
ACCORDING TO THE AVAILABLE INFORMATION, DEVICE MALFUNCTION.
Patient problems: No Information
MAUDE report 7105977 ↗InjuryNov 17, 2017Break
ACCORDING TO THE AVAILABLE INFORMATION TITAN OTR WAS EXPLANTED DUE TO TEAR IN TUBING AT EXIT POINT.
Patient problems: No Information
MAUDE report 7042488 ↗InjuryOct 24, 2017Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, TITAN OTR WAS EXPLANTED DUE TO REPORTED MALFUNCTION AND PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 6972996 ↗InjuryOct 4, 2017Break
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE TUBING BROKE AT THE LEFT SIDE AT CYLINDER AND THE RESERVOIR TUBING BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6913838 ↗
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-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-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Z-1370-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; 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-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-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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-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 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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