Titan ES8916Recalls & reported problems
Coloplast A/S · Scrotal 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 Titan ES8916 is a Coloplast scrotal cylinder set with a pump, used as a penile implant for impotence. Most of the 68 reports describe the tubing cracking or breaking, which led to the implant being taken out and replaced, or the cylinder being the wrong size or too short. Others mention erosion and infection with tubing exposed through the scrotum, leaking fluid, and pain. There were 60 injuries and no deaths.
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
- 67
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 05708932487320), received between Jul 24, 2017 and May 21, 2026 — classified as 59 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (14 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
- Fracture14
- Adverse Event Without Identified Device or Use Problem10
- Insufficient Device Problem Information8
- Inadequacy of Device Shape and/or Size7
- Break6
- Fluid/Blood Leak6
- Deflation Problem3
- Inflation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Information16
- Unspecified Infection11
- Erosion7
- No Known Impact Or Consequence To Patient4
- Pain4
- Bacterial Infection1
- Deformity/ Disfigurement1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A BREAK IN TUBING BY THE RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241876 ↗InjuryMay 21, 2026Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANTS WERE REMOVED AND REPLACED DUE TO INCORRECT SIZING. THE PHYSICIAN ONLY WANTED TO REPLACE THE CYLINDERS SO CUT THEM IN. THE RESERVOIR WAS NOT REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25241105 ↗InjuryApr 17, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A FRACTURE IN THE LEFT TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912742 ↗InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED DUE TO ERODED AND INFECTED. IT WAS NOTED THAT THE TUBING WAS EXPOSED FROM THE SCROTUM.
Patient problems: Erosion; Unspecified Infection
MAUDE report 24852057 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EROSION.
Patient problems: Erosion
MAUDE report 24661278 ↗InjuryFeb 5, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING FRACTURE MALFUNCTION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273436 ↗InjuryDec 31, 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 TOO SHORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23937182 ↗InjuryNov 3, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A CRACK IN THE TUBING NEAR THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23450812 ↗InjuryJun 2, 2025Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A CYLINDER CROSSOVER/EROSION. THE CYLINDER WAS OUTSIDE THE CORPORA.
Patient problems: Erosion
MAUDE report 22124533 ↗InjuryMay 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22110043 ↗InjuryMay 1, 2025Deflation Problem; Inflation Problem; Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking; Deflation Problem; Inflation Problem; Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking
ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT'S PRIVATE PARTS ARE VERY SENSITIVE TO TOUCH. INFLATING/ DEFLATING THE PUMP OF THE DEVICE IS VERY HARD AND THE PUMP IS NOT EASY TO SQUEEZE. THE HEAD OF THE PATIENT¿S PENIS IS DANGLING DOWN AND HE HAS LOST 2 INCHES FROM HIS PENIS. THE PATIENT IS CONCERNED THAT THE IMPLANT IS NOT SIZED RIGHT.
Patient problems: Deformity/ Disfigurement; Discomfort
MAUDE report 21943776 ↗InjuryApr 30, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS MALFUNCTIONING. THE DEVICE WAS LATER EXPLANTED AND REPLACED DUE TO A TUBING BREAK FROM THE LEFT CYLINDER TO PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934893 ↗InjuryApr 24, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED AS THE PUMP WAS LEAKING, WHICH WAS CAUSED BY A TUBING TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21904322 ↗InjuryFeb 20, 2025Fracture; Air/Gas in Device; Fracture; Air/Gas in Device
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AIR IN SYSTEM CAUSED BY TEAR ON CYLINDER TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426827 ↗InjuryNov 5, 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 DUE TO INFECTION. INTRAVENOUS ANTIBIOTICS WERE PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 20612652 ↗InjuryOct 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20568803 ↗InjuryMar 6, 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 SCROTAL INFECTION.
Patient problems: Unspecified Infection
MAUDE report 18851952 ↗InjuryDec 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE BEGAN LEAKING AND WAS NO LONGER OPERATIONAL. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18324503 ↗InjuryNov 28, 2023Break; Break
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BREAK IN TUBING RIGHT AT THE INPUT JUNCTION ON PROXIMAL PORTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18220871 ↗InjuryMay 24, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO FLUID LOSS. A MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16992155 ↗InjuryApr 23, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO SIZE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792767 ↗InjuryApr 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO AN UNSPECIFIED REASON. THE RESERVOIR WAS RETAINED AND REUSED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773994 ↗InjuryMar 30, 2023Material Puncture/Hole; Inadequacy of Device Shape and/or Size; Material Puncture/Hole; Inadequacy of Device Shape and/or Size
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A HOLE. AN ANEURYSM WAS ALSO NOTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16653076 ↗InjuryMar 28, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THE RIGHT CYLINDER TUBING WAS RUPTURED. THE RESERVOIR WAS RETAINED AND REUSED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625354 ↗InjuryFeb 27, 2023Fracture; Pumping Problem; Fracture; Pumping Problem
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO NOT PUMPING. A FRACTURE WAS ALSO NOTED NEAR THE PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16448440 ↗
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-1375-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; 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-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-1359-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Z-1365-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Z-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; 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-1361-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Z-1374-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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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