Titan 90-9916SNCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05708932323604), received between Jul 24, 2017 and Aug 6, 2021 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE STOPPED WORKING. IT WAS EXPLANTED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 12288831 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED DUE TO AN UNSPECIFIED FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096542 ↗
• InjuryMay 18, 2021Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED DUE TO A LEAK IN THE TUBING NEAR THE PUMP. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841121 ↗
• MalfunctionFeb 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, RESERVOIR TUBING LEAK (TEAR)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 11291954 ↗
• MalfunctionDec 30, 2020Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, THE RESERVOIR MIGRATED INTO THE SCROTUM AND THE RIGHT CYLINDER CAME OUT OF THE CORPORA. THE DEVICE WAS REMOVED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11096164 ↗
• InjuryApr 19, 2019Mechanical Problem; Mechanical Problem

  ACCORDING TO THE AVAILABLE INFORMATION, MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8533882 ↗
• InjuryJan 12, 2018Material Erosion; Extrusion; Extrusion

  ACCORDING TO THE AVAILABLE INFORMATION, PATIENT EXPERIENCED DEVICE EROSION/EXTRUSION.

  Patient problems: Erosion

  MAUDE report 7186127 ↗
• InjuryOct 26, 2017Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, A TUBING LEAK AT CYLINDER JUNCTION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6980844 ↗
• InjurySep 21, 2017Material Frayed; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP TUBING FRAYED AND LEAKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882873 ↗
• InjuryJul 24, 2017Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, REPOSITION.

  Patient problems: No Information

  MAUDE report 6739115 ↗
• InjuryJul 24, 2017Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, INCORRECT SIZE.

  Patient problems: No Code Available; No Information

  MAUDE report 6739028 ↗
• InjuryJul 24, 2017Break

  ACCORDING TO THE AVAILABLE INFORMATION, BROKEN TUBING AND SCAR TISSUE.

  Patient problems: Scar Tissue

  MAUDE report 6737726 ↗

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-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• 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-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

…and 3 more.