Titan ES8816Recalls & reported problems
Coloplast A/S · Infrapubic Zero Degree Angle Cylinder Set with Pump · Class 3 · Implant
Quick summary
This Titan ES8816 is a Coloplast penile implant set, a pair of inflatable cylinders with a pump placed surgically to treat impotence. The 36 reports mostly describe implants that had to be removed or replaced because they would not fill, leaked, cracked, or had a hole in the tubing, along with swelling, infection and pain at the implant site. No deaths and 34 injuries are reported. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 05708932487184), received between Jul 24, 2017 and May 4, 2026 — classified as 34 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size10
- Adverse Event Without Identified Device or Use Problem6
- Inflation Problem4
- Leak/Splash4
- Fracture3
- Insufficient Device Problem Information3
- Mechanical Problem3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Information7
- Unspecified Infection5
- No Known Impact Or Consequence To Patient3
- Pain2
- Perforation2
- Deformity/ Disfigurement1
- Erosion1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO NOT FILLING [INFLATION ISSUE]. THE RESERVOIR WAS NOT REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068423 ↗InjuryApr 7, 2026Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANTED PUMP WAS REPOSITIONED. IT WAS NOTED THAT THE DEVICE IS FULLY FUNCTIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809110 ↗InjuryMar 2, 2026No Apparent Adverse Event; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO IT BEING 13 YEARS OLD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484448 ↗InjuryNov 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED TO CONVERT FROM NARROW 16CM TO STANDARD 16CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23671992 ↗InjurySep 18, 2025Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A HOLE IN THE PUMP TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23089004 ↗InjuryApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A LEAK IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901373 ↗InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO AN INFECTION AT THE CYLINDERS WITH ACCOMPANIED SWELLING AND INFLAMMATION. THE DEVICE WAS NOT REPLACED.
Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 21677246 ↗InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT IS EXPERIENCING A BLADDER PROBLEM, AND BELIEVES IT MAY BE INFECTED WHICH IS AFFECTING HIS IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 21664860 ↗InjuryMar 7, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE IMPLANT BEING UNDERSIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21547014 ↗InjuryFeb 5, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THE IMPLANT WAS TOO SHORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313601 ↗InjuryDec 30, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21042064 ↗InjuryNov 26, 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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20787134 ↗InjurySep 12, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A SIZE ISSUE AND PATIENT PREFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20201768 ↗InjuryApr 1, 2024Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BROKEN CYLINDER TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014814 ↗InjuryFeb 21, 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 THE PUMP ERODING THROUGH THE SKIN. THE PATIENT HAD A HEMATOMA AND PUSHED THE TUBING UP.
Patient problems: Erosion; Hematoma
MAUDE report 18748247 ↗InjuryDec 12, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO SIZING / PATIENT PREFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18310544 ↗InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO AVAILABLE INFORMATION, THE PATIENT WITH THIS DEVICE EXPERIENCED PAIN AND ISCHEMIA AFTER IMPLANT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Ischemia; Pain
MAUDE report 16858194 ↗InjuryMar 10, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THE BREAK WAS AT THE CYLINDER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16519643 ↗InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
TITLE: COMPARISON OF PATIENT-REPORTED OUTCOMES AFTER PENILE PROSTHESIS PLACEMENT IN MEN WITH AND WITHOUT PEYRONIE'S DISEASE. WE EVALUATED OUTCOMES IN PATIENTS UNDERGOING PENILE PROTHESIS (PP) IMPLANTATION FOR ERECTILE DYSFUNCTION (ED) AND CONCURRENT PEYRONIE¿S DISEASE (PD). A CLINICIAN-DEVELOPED SURVEY TO ASSESS SATISFACTION WAS SENT TO 354 PATIENTS WHO UNDERWENT PP PLACEMENT FROM 2012¿2018 BY A SINGLE-SURGEON. RESULTS WERE COMPARED BASED ON THE PRESENCE OR ABSENCE OF CONCURRENT PD. 79 PATIENTS COMPLETED THE SURVEY (RESPONSE RATE 22%), INCLUDING 38 PATIENTS (48%) WITH CONCURRENT ED AND PD (ED/PD). MEAN FOLLOW-UP WAS 31 MONTHS (STANDARD DEVIATION 19). 87% FELT THEIR CONDITION WAS ¿VERY MUCH¿ OR ¿MUCH¿ IMPROVED. THERE WAS NO SIGNIFICANT DIFFERENCE IN PATIENT-REPORTED OVERALL SATISFACTION WITH THEIR PP OR SATISFACTION WITH CURRENT PENILE LENGTH/GIRTH BASED ON THE PRESENCE OR ABSENCE OF PD. 87% OF PATIENTS WITH PD WERE SATISFIED WITH THEIR DEGREE OF PENILE STRAIGHTENING AFTER PP PLUS OR MINUS CONCURRENT STRAIGHTENING MANEUVERS SUCH AS MODELING, PLICATION, OR INCISION/GRAFTING. SUB-GROUP ANALYSES WERE PERFORMED TO EVALUATE OUTCOMES IN THOSE WITH CONCURRENT PD/ED WHO REQUIRED PLAQUE INCI
Patient problems: Deformity/ Disfigurement; Numbness; Pain; Unspecified Infection
MAUDE report 16512962 ↗InjuryJan 30, 2023Inflation Problem; Inflation Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO NOT ABLE TO INFLATE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16268797 ↗InjuryOct 24, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRES REPLACEMENT DUE TO AUTO DEFLATING. THE IMPLANT IS AUTO DEFLATING AND NOT PERFORMING CONSISTENTLY ON INFLATION AND DEFLATION. THE PHYSICIAN IS WELL VERSED IN DEVICE DEFLATION AND INFLATION AND HAS BEEN UNABLE TO GET PATIENT'S DEVICE TO PERFORM NORMALLY AND CONSISTENTLY. DEVICE REMAINS IMPLANTED AND REPLACEMENT HAS BEEN SCHEDULED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15661594 ↗InjuryOct 5, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE AVAILABLE INFORMATION THE TITAN WAS IMPLANTED ON (B)(6) 2021 AND REVISED ON (B)(6) 2021 DUE TO DISTAL CROSSOVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12580546 ↗MalfunctionMar 10, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS UNDERSIZED AT IMPLANT. THE DEVICE WAS REPLACED. IT WAS NOTED THAT THE DEVICE WAS NOT REMOVED FOR MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11453083 ↗MalfunctionJun 4, 2020Inflation Problem; Leak/Splash; Inadequacy of Device Shape and/or Size; Inflation Problem; Leak/Splash; Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, AN APPROXIMATELY THREE YEAR OLD TITAN WAS REPORTED TO HAVE AN AIR LEAK. THE PATIENT WAS UNDERSIZED. THE DEVICE WAS REMOVED AND REPLACED. THE SURGEON NOTED AIR IN THE DEVICE. THE PHYSICIAN INSPECTED THE PUMP BUT COULD NOT IDENTIFY A LEAK. THE PATIENT WAS HAVING DIFFICULTY INFLATING THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10120794 ↗InjuryDec 31, 2019Break; Leak/Splash; Break; Leak/Splash
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED DUE TO FLUID LOSS AND REPLACED WITH A NEW DEVICE. TUBING BREAK WAS ALSO REPORTED.
Patient problems: No Information
MAUDE report 9535760 ↗
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-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-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
- Z-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; 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-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; 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-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; 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-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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.