Titan 90-9000KCOTRRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05708932319744), received between Jul 19, 2017 and Mar 2, 2026 — classified as 24 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A TOUCH DUE TO AN UNKNOWN MALFUNCTION. NOTED TO BE A 15-YEAR-OLD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490302 ↗
• InjuryFeb 16, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344485 ↗
• InjuryDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878815 ↗
• InjuryNov 27, 2024Failure to Pump; Failure to Pump

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO THE PUMP NOT PUMPING, IT WAS NOTED THERE WAS NO BREAK IN THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792970 ↗
• InjuryNov 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18176759 ↗
• InjuryNov 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE TUBING LEAKED. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18068337 ↗
• InjuryJun 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTED INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NO FLUID. THE OLD RESERVOIR WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170168 ↗
• InjuryFeb 17, 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 16398537 ↗
• InjuryNov 4, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A MALFUNCTION. THE PATIENT WAS EXPERIENCING ERECTILE DYSFUNCTION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724655 ↗
• InjuryAug 9, 2022Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A TUBING BREAK. THE TUBING TO THE RESERVOIR BROKE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193547 ↗
• InjurySep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO FLUID LOSS OF THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460910 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT EXPERIENCED IMPENDING EROSION. THE DEVICE WAS REMOVED/REPLACED.

  Patient problems: Erosion

  MAUDE report 11140428 ↗
• MalfunctionDec 3, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, REPORTED: "REMOVED ALL INCLUDING RESERVOIR". THE DEVICE WAS REMOVED/REPLACED. 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 10942700 ↗
• MalfunctionNov 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS NON-FUNCTIONING. THERE WAS A TUBING LEAK ON THE CYLINDER. THE DEVICE WAS REMOVED/REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10905045 ↗
• MalfunctionOct 26, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, IT WAS DIFFICULT TO START INITIAL INFLATION USING THE PUMP. THE DEVICE WAS REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10733751 ↗
• MalfunctionSep 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION RECEIVED FOR RECORD #610384. ACCORDING TO THE AVAILABLE INFORMATION THE INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON (B)(6) 2012 REMOVED AND REPLACED ON (B)(6) 2020 AS THE DEVICE ¿WENT FLAT¿, LEAKS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, QUALITY CANNOT CONFIRM ANY OBSERVATIONS OR COMMENT ON THE CONDITION OF THE PRODUCT. IF THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT WILL BE RE-EVALUATED ACCORDING TO PROCEDURES. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NON-CONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10584312 ↗
• InjuryAug 14, 2020Migration; Migration

  THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION RECEIVED FOR RECORD #601873. ACCORDING TO THE AVAILABLE INFORMATION THE INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON (B)(6) 2008 AND REMOVED ON (B)(6) 2020 DUE TO DISPLACEMENT/INFECTION. ADDITIONAL INFORMATION RECEIVED FROM THE PATHOLOGY COORDINATOR INDICATED: ¿EXPLANTED PENILE PROSTHESIS DUE TO: ¿DISPLACEMENT/INFECTION¿. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. AS EXAMINATION OF THE DEVICE MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS AS TO THE REASON FOR SURGICAL INTERVENTION. THE REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE REVEALED NO TRENDS FOR THIS LOT. REVIEW OF NONCONFORMING REPORTS REVEALED NO NONCONFORMANCES FOR THIS LOT. NO CAPAS ARE ASSOCIATED WITH THIS LOT.

  Patient problems: Unspecified Infection

  MAUDE report 10408963 ↗
• InjuryAug 7, 2020Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, INFECTION/DISPLACEMENT WAS REPORTED. THE DEVICE WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 10381901 ↗
• MalfunctionMar 5, 2020Leak/Splash; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS NOT HOLDING FLUID. THE DEVICE WAS REPLACED WITH ANOTHER INFLATABLE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9795215 ↗
• InjuryNov 8, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION WAS REPORTED. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER INFLATABLE DEVICE.

  Patient problems: No Information

  MAUDE report 9298181 ↗
• InjuryAug 26, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A DEVICE MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8932478 ↗
• InjuryJul 20, 2018Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, TUBING BROKEN IN BOTH CYLINDERS NEAR PUMP.

  Patient problems: No Information

  MAUDE report 7707808 ↗
• InjuryJun 30, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ACCORDING TO THE AVAILABLE INFORMATION, SHARP DISTAL TIPS.

  Patient problems: No Information

  MAUDE report 7653785 ↗
• InjuryApr 13, 2018Material Rupture; Break; Material Rupture

  ACCORDING TO THE AVAILABLE INFORMATION, TITAN OTR WAS EXPLANTED DUE TO BREAK IN TUBING.

  Patient problems: No Information

  MAUDE report 7428386 ↗
• InjuryMar 5, 2018Material Rupture; Crack; Material Rupture

  ACCORDING TO THE AVAILABLE INFORMATION, TITAN OTR WAS EXPLANTED DUE TO CRACK IN TUBING GOING FROM PUMP TO CYLINDER.

  Patient problems: Failure of Implant; No Information

  MAUDE report 7314388 ↗

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-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

…and 3 more.