Titan ESR916Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05708932487641), received between Jul 24, 2017 and Nov 11, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO WITH A MALLEABLE DUE TO A TUBING BREAK BY THE CYLINDER AND PATIENT PREFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522637 ↗
• InjurySep 9, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS NOT INFLATING. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009752 ↗
• InjuryApr 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND NOT REPLACED DUE TO NON-USE UNSPECIFIED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762173 ↗
• InjuryJul 15, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION OF THE TUBING TO THE LEFT CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741540 ↗
• InjuryMar 21, 2024Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING BREAK BY THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950808 ↗
• InjuryFeb 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691739 ↗
• InjuryDec 26, 2023Premature Activation; Premature Activation

  ACCORDING TO THE AVAILABLE INFORMATION THERE WAS A FAILURE IN THE VALVE IN THAT IT ACTIVATED ITSELF WITHOUT MANIPULATION OF THE PATIENT AND THE CYLINDERS WERE FILLED. THE PRODUCT WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393532 ↗
• InjuryNov 16, 2023Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO UNABLE TO INFLATE THE PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18152806 ↗
• InjuryJun 6, 2023Failure to Pump; Failure to Pump

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO A PUMP FAILURE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075874 ↗
• InjuryJun 5, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO FLUID LOSS. THERE WAS A HOLE IN THE TUBING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059995 ↗
• InjuryAug 29, 2022Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO A TUBING BREAK. THE BREAK WAS AT THE PUMP. A MALLEABLE DEVICE WAS IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316696 ↗
• InjuryMar 16, 2022Fracture; Fracture

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO TUBING LEADING FROM THE RESERVOIR BROKEN IN MULTIPLE LOCATIONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13783178 ↗
• InjuryFeb 24, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED BECAUSE THE RIGHT SIDE CYLINDER EXTRUDED THROUGH THE DISTAL URETHRA. A MALLEABLE DEVICE WAS IMPLANTED ON THE LEFT SIDE ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13593865 ↗
• InjuryJun 8, 2021Fluid/Blood Leak; Pumping Problem; Fluid/Blood Leak; Pumping Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO A POTENTIAL LEAD IN THE PUMP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958748 ↗
• InjuryApr 17, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, PUMP WOULD NOT INFLATE CYLINDERS.

  Patient problems: No Information

  MAUDE report 8524334 ↗
• InjuryApr 2, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT STOPPED INFLATING.

  Patient problems: No Information

  MAUDE report 8473256 ↗
• InjuryAug 22, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, THE PHYSICIAN REMOVED AN OTR DEVICE AND REPLACED ALL COMPONENTS. THERE WAS A FLUID LOSS OF UNKNOWN CAUSE IN ORIGINAL DEVICE.

  Patient problems: No Information

  MAUDE report 7804412 ↗
• InjuryApr 13, 2018Break

  ACCORDING TO THE AVAILABLE INFORMATION, RESERVOIR TUBING BREAK 2" ABOVE THE REINFORCED TUBING.

  Patient problems: No Information

  MAUDE report 7428376 ↗
• InjuryNov 14, 2017Material Rupture; Torn Material; Material Rupture

  ACCORDING TO THE AVAILABLE INFORMATION TITAN OTR WAS EXPLANTED DUE TO TORN TUBING NEAR PUMP.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7029309 ↗
• InjuryJul 24, 2017Crack

  ACCORDING TO AVAILABLE INFORMATION, TUBING CRACKED FROM PUMP.

  Patient problems: No Information

  MAUDE report 6736188 ↗

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, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; 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-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis

…and 3 more.