Titan 91-9480SCRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05708932519847), received between Jan 12, 2018 and Aug 27, 2024 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE ADDITIONAL INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO CONNECTORS FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081536 ↗
• InjuryJun 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT UNDERWENT A REVISION TO REMOVE THE LEFT READ TIP EXTENDER FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559073 ↗
• MalfunctionMay 9, 2024Air/Gas in Device; Air/Gas in Device

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS AN ISSUE ON THE TABLE DOING SURROGATE RESERVOIR. AIR WAS PULLED INTO THE PUMP BULB UPON SQUEEZING IT. THIS WAS CLEARED BY CLAMPING THE WHITE TUBES, PRESSING THE BUTTON, SQUEEZING THE BULB AND ASPIRATING WITH THE SYRINGE. HOWEVER, AIR WAS SUCKED IN AGAIN. THE GREEN TIP [ACCESSORY] AND SYRINGE WERE SWAPPED, AND THE SITUATION WAS SOLVED. THERE WAS NO ADVERSE EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282289 ↗
• MalfunctionMay 8, 2024Air/Gas in Device; Air/Gas in Device

  ACCORDING TO THE AVAILABLE INFORMATION, DURING PRIMING, THE DEVICE HAD A SMALL ISSUE WITH AIR BEING PUMPED INTO THE PUMP. IT WAS NOTED THAT THIS WAS A FIRST-TIME SCRUB NURSE DOING THE PREPARATION. THE ISSUE WAS NOTED AGAIN ON THE TABLE DOING SURROGATE RESERVOIR. AIR WAS PULLED INTO THE PUMP BULB UPON SQUEEZING IT. THIS WAS CLEARED BY CLAMPING THE WHITE TUBES, PRESSING THE BUTTON ON THE PUMP, SQUEEZING THE BULB AND ASPIRATING WITH THE SYRINGE. BOTH TIMES THE AIR WAS SUCKED IN AGAIN. THE GREEN TIP [ACCESSORY] AND SYRINGE WERE SWAPPED, AND THE SITUATION WAS SOLVED. THERE WAS NO ADVERSE EFFECT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271530 ↗
• InjuryMay 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE REAR TIP EXTENDER ON THE LEFT SIDE WAS REMOVED AND REPLACED ON THE LEFT SIDE DUE TO INCORRECT SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230300 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE FAILED DUE TO A BREAK. THE DEVICE BROKE DURING EXPLANTATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806130 ↗
• MalfunctionNov 23, 2022Material Deformation; Material Deformation

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO NOT HOLLOWED OUT FULLY. THE PHYSICIAN STATED THAT THE PINK TIPS IN THE ASSEMBLY KIT DO NOT SQUIRT PROPERLY AND ARE NOT HOLLOWED OUT FULLY. THE PHYSICIAN PRESUMES THAT WHEN THE TIPS WERE CUT, THEY SEALED, RENDERING THEM UNABLE TO FUNCTION PROPERLY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15858554 ↗
• InjurySep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REVISION DUE TO RESERVOIR FLUID. THE FLUID WAS INCREASED IN THE RESERVOIR. THE RESERVOIR, CYLINDERS AND PUMP WERE RETAINED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432524 ↗
• InjuryDec 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, DEVICE REQUIRED REVISION DUE TO LEAK IN THE LEFT CYLINDER TUBING. NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043587 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. A NEW MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 12220943 ↗
• InjuryMay 13, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO AVAILABLE INFORMATION, DURING THE EXPLANT OF A COMPETITOR'S DEVICE, THE PATIENT EXPERIENCED A PERFORATED URETHRA. THE IMPLANT OF THE COLOPLAST DEVICE WAS ABANDONED.

  Patient problems: Perforation

  MAUDE report 11820728 ↗
• MalfunctionNov 23, 2020Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING WAS REVISED. THE DOCTOR SHORTENED THE TUBING LENGTH FROM THE CYLINDERS TO THE PUMP, DUE TO KINKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10886478 ↗
• InjuryJul 5, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  ADDITIONAL INFORMATION INDICATED THE REVISION TOOK PLACE BECAUSE THE PATIENT HAD A HARD TIME WORKING THE ONE TOUCH DEVICE. THE PHYSICIAN WAS ABLE TO OPERATE THE DEVICE, BUT THOUGHT THE PATIENT WOULD HAVE AN EASIER TIME WITH THE TITAN GENESIS PUMP.

  Patient problems: No Information

  MAUDE report 8764927 ↗
• InjuryMay 8, 2019Fracture; Inflation Problem; Mechanical Problem; Fracture; Inflation Problem; Mechanical Problem

  ADDITIONAL INFORMATION INDICATED PUMP WOULD NOT INFLATE.

  Patient problems: No Information

  MAUDE report 8593096 ↗
• InjuryJan 12, 2018Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION IN MEDWATCH UF/IMPORTER # (B)(4) - POSSIBLE DEVICE LEAK.

  Patient problems: No Information

  MAUDE report 7186170 ↗

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-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

…and 3 more.