Titan ESR922Recalls & reported problems
Coloplast A/S · Scrotal OTR Zero Degree Angle Cylinder Set with Pump · Class 3 · Implant
Quick summary
This Titan ESR922 is a Coloplast scrotal implant set with a pump, used to treat impotence. Across 54 reports, no deaths were described and 45 injuries were reported, with 9 malfunctions. Most reports describe the implant breaking or cracking — especially in the tubing and pump — along with leaking fluid and cylinders that would not hold pressure or inflate, often leading to the device being removed and replaced. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 05708932487702), received between Jul 24, 2017 and May 18, 2026 — classified as 45 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
- Break9
- Insufficient Device Problem Information7
- Fracture6
- Device Operates Differently Than Expected4
- Fluid/Blood Leak4
- Inflation Problem4
- Crack3
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Information19
- No Known Impact Or Consequence To Patient4
- Failure of Implant2
- No Code Available2
- No Consequences Or Impact To Patient2
- Discomfort1
- Hernia1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Fracture
ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25202602 ↗InjuryFeb 24, 2025Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING MALFUNCTION [FRACTURE] AT THE PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447799 ↗InjurySep 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO UNKNOWN REASONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20150656 ↗InjuryAug 6, 2024Malposition of Device; Malposition of Device
ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED TO RE- TUNNEL [REPOSITION] THE LEFT CYLINDER, WHICH ULTIMATELY LED TO THE DEVICE BEING REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19918929 ↗InjuryJun 26, 2024Fracture; Fracture
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING FRACTURE AT THE RESERVOIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19616468 ↗InjuryJan 8, 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 DEVICE NO LONGER WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18464758 ↗InjuryDec 26, 2023Pressure Problem; Pressure Problem
ACCORDING TO THE AVAILABLE, WHEN FILLING THE CYLINDERS, THE PROSTHESIS DID NOT SUSTAIN THE PRESSURE AND THE LIQUID RETURNS TO THE RESERVOIR. THE DEVICES WERE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18392947 ↗MalfunctionDec 13, 2023Pumping Problem; Pumping Problem
ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT COMPLAINED OF DIFFICULTY IN OPERATING THE IMPLANT. CLINICAL EXAMINATION REVEALED A MALFUNCTION IN THE PUMP. DEVICE WAS NOT REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320965 ↗InjuryJun 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO AN UNSPECIFIED MALFUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056877 ↗InjuryMay 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A MALFUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16989832 ↗InjuryApr 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING LEAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16704963 ↗InjuryMar 17, 2023Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THE BREAK WAS AT THE PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16565357 ↗InjuryFeb 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A LEAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16368730 ↗InjuryDec 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A MALFUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16044692 ↗InjurySep 1, 2022Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15334109 ↗InjuryAug 16, 2022Fracture; Fracture
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THE BREAK WAS NOTED BETWEEN A CYLINDER AND THE PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15236780 ↗InjuryAug 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A MALFUNCTION. NO OTHER ADVERSE PATIENT INFORMATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15163988 ↗MalfunctionNov 17, 2021No Apparent Adverse Event; No Apparent Adverse Event
AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEFT TUBING MALFUNCTION AT PUMP JUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12833397 ↗InjurySep 14, 2021Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON (B)(6) 2012 AND REVISED ON (B)(6) 2021 DUE TO THE DEVICE WAS NOT INFLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12471084 ↗InjuryJul 2, 2021Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
ACCORDING TO AVAILABLE INFORMATION, THERE WAS DIFFICULTY AND PAIN WITH CYCLING OF THIS DEVICE. THERE WAS LOSS OF RIGIDITY DUE TO SLOW FLUID LOSS DUE TO SEMIPERMEABLE NATURE OF THE RESERVOIR.
Patient problems: Implant Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 12109372 ↗MalfunctionApr 21, 2021Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, FLUID LOSS OCCURRED. THE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11701800 ↗MalfunctionApr 19, 2021Failure to Pump; Insufficient Device Problem Information; Physical Resistance/Sticking; Failure to Pump; Insufficient Device Problem Information; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED FURTHER REPORTED THAT THE PUMP WOULD NOT PUMP; IT WAS EXTREMELY HARD AND THEY COULD NOT GET IT GOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11686204 ↗MalfunctionJan 29, 2021Break; Break
ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, TUBING BREAK. DEVICE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED 01/05/2020: THE BREAK WAS BETWEEN THE PUMP AND LEFT CYLINDER. APPROXIMATELY 1CM FROM THE PROTECTIVE COLLAR OF THE TUBING/PUMP JUNCTION. 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 11255576 ↗MalfunctionDec 4, 2020Break; Break
ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, TUBING MALFUNCTION, TOWARDS RESERVOIR. THE DEVICE WAS REMOVED/REPLACED. DEVICE BEING SENT OUT MONDAY (11/06/20) ADDITIONAL INFORMATION RECEIVED ON 11/10/2020: TUBING BREAK. EXPLANTED DEVICE RECEIVED. THE LOT NUMBER 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 10946905 ↗MalfunctionNov 24, 2020Crack; Crack
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: No Known Impact Or Consequence To Patient
MAUDE report 10896470 ↗
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-1371-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
- Z-1372-2023 · Mar 1, 2023 · Open, ClassifiedTitan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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-1367-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; 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-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; 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
- 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-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1360-2023 · Mar 1, 2023 · Open, ClassifiedTitan Pump Assembly, Catalog Number 5177701400; 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.