Titan ESR818Recalls & 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
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05708932487542), received between Jul 23, 2017 and Dec 3, 2024 — classified as 19 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (8 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
- Break8
- Inflation Problem5
- Fluid/Blood Leak3
- Deflation Problem2
- Leak/Splash2
- Adverse Event Without Identified Device or Use Problem1
- Device Operates Differently Than Expected1
- Hole In Material1
Patient problems
- No Information9
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient4
- No Code Available2
- Failure of Implant1
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 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 PATIENT COMPLAINING OF PAIN.
Patient problems: Pain
MAUDE report 20832183 ↗InjuryOct 14, 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 20439035 ↗InjuryJan 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED AS IT HAD STOPPED WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18526328 ↗InjurySep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A LEAK. THERE WAS NO FLUID IN THE RESERVOIR. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15504057 ↗InjuryOct 4, 2021Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem
AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENTS OTR PUMP WOULD NOT INFLATE OR DEFLATE PROPERLY. THE DEVICE WAS EXPLANTED AND REPLACED WITH A TITAN TOUCH. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12573781 ↗MalfunctionAug 7, 2020Break; Break
ACCORDING TO THE AVAILABLE INFORMATION, BROKEN LINE. DEVICE REVISED. RESERVOIR NOT REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10381947 ↗MalfunctionMar 30, 2020Break; Break
ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A BREAK IN THE TUBING BY THE RIGHT CYLINDER. THE RESERVOIR WAS RETAINED AND THE PUMP WAS REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9899358 ↗InjuryFeb 7, 2020Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, THE CYLINDERS NO LONGER INFLATED. IT WAS NOTED THAT THE PHYSICIAN THOUGHT IT HAD MORE TO DO WITH THE RESERVOIR. A LARGER RESEVIOR WAS IMPLANTED AND CYLINDERS WERE REPLACED.
Patient problems: No Information
MAUDE report 9682769 ↗InjuryOct 4, 2019Break; Leak/Splash; Break; Leak/Splash
ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS A LEAK IN THE DEVICE. THE DEVICE WAS IMPLANTED IN 2013.
Patient problems: No Information
MAUDE report 9157952 ↗InjuryJul 23, 2019Break; Inflation Problem; Break; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, TUBING BREAK. ADDITIONAL INFORMATION RECEIVED ALSO STATED MALFUNCTIONING IPP (WOULD NOT INFLATE).
Patient problems: No Information
MAUDE report 8818372 ↗InjuryMay 24, 2019Break; Positioning Problem; Break; Positioning Problem
ADDITIONAL INFORMATION RECEIVED STATED TUBING BREAKDOWN AT PUMP; RIGHT CYLINDER MALPOSITION.
Patient problems: No Information
MAUDE report 8641925 ↗InjuryApr 19, 2019Inflation Problem; Inflation Problem
ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION-NOT INFLATING.
Patient problems: No Information
MAUDE report 8533881 ↗InjuryMar 26, 2018Break; Fluid/Blood Leak
ACCORDING TO THE AVAILABLE INFORMATION, FLUID LOSS, BREAK IN TUBING PUMP TO RESERVOIR.
Patient problems: No Code Available
MAUDE report 7369895 ↗InjuryMar 21, 2018Device Operates Differently Than Expected
ACCORDING TO THE AVAILABLE INFORMATION, PLACEMENT OF PREVIOUS IMPLANT WAS NOT SUFFICIENT.
Patient problems: No Code Available
MAUDE report 7356912 ↗InjuryJan 12, 2018Hole In Material
ACCORDING TO THE AVAILABLE INFORMATION, NEEDLE PRICK IN RIGHT CYLINDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7186964 ↗InjuryJan 5, 2018Break
ACCORDING TO THE AVAILABLE INFORMATION, TITAN OTR WAS EXPLANTED DUE TO A EXHAUST TUBING BREAK BY THE CYLINDER JUNCTION.
Patient problems: No Information
MAUDE report 7168182 ↗InjuryJan 4, 2018Material Fragmentation; Material Frayed; Inflation Problem; Material Fragmentation; Material Frayed
ACCORDING TO THE AVAILABLE INFORMATION, UNKNOWN ISSUE WITH INFLATION.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 7165576 ↗InjuryNov 27, 2017Break
ACCORDING TO THE AVAILABLE INFORMATION, DEVICE MALFUNCTION - ONE SIDE BROKEN, REPLACED CYLINDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7061075 ↗InjuryJul 24, 2017Inadequacy of Device Shape and/or Size
ACCORDING TO THE AVAILABLE INFORMATION, CYLINDER ARE TOO SHORT, GLANS IS FLOPPY.
Patient problems: No Information
MAUDE report 6739086 ↗InjuryJul 24, 2017Leak/Splash
ACCORDING TO THE AVAILABLE INFORMATION, POTENTIAL LEAK IN TUBING WHERE TUBING MEETS CYLINDER.
Patient problems: No Information
MAUDE report 6739025 ↗InjuryJul 23, 2017Deflation Problem
ACCORDING TO AVAILABLE INFORMATION, DEVICE WAS DECOMPRESSED, NO FLUID. IT WAS NON-FUNCTIONAL.
Patient problems: Failure of Implant
MAUDE report 6734883 ↗
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-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-1366-2023 · Mar 1, 2023 · Open, ClassifiedTitan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
- Z-1369-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Z-1364-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Z-1368-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
- Z-1363-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; 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-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-1362-2023 · Mar 1, 2023 · Open, ClassifiedTitan Touch NB Infr Zero 18cm, Catalog Number EN28182400; 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
…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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