Titan ES8820Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 05708932487245), received between Jul 24, 2017 and Jun 2, 2026 — classified as 163 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Fracture” (34 reports).

1 FDA recall record name this device's identifier, 1 still open.

17 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 1, 2023Open, Classified

   A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.

   Z-1372-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 192 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A SUBCLINICAL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25365408 ↗
• InjuryMay 19, 2026Inadequacy of Device Shape and/or Size; Malposition of Device

  ACCORDING TO THE AVAILABLE, IMPLANT REMOVED AND REPLACED DUE TO INCORRECT SIZING -- UNDERSIZED AND MALPOSITION. ONLY THE CYLINDER AND PUMP WERE REPLACED. THE ORIGINAL RESERVOIR WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216989 ↗
• InjuryMay 4, 2026Migration

  ACCORDING TO THE AVAILABLE INFORMATION THE TITAN IMPLANT REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO A DISPLACEMENT OF THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069385 ↗
• InjuryMay 1, 2026Disconnection

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING CONNECTER COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056922 ↗
• InjuryApr 30, 2026Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH AN AMS DEVICE DUE TO MECHANICAL COMPLICATION AND DISPLACEMENT OF PENILE IMPLANT. IT WAS NOTED THE PATIENT BEGAN EXPERIENCING AN ANEURYSMAL DEFECT IN THE MORE RIGHT PROXIMAL ASPECT OF HIS PENIS CAUSING DISCOMFORT AND MALFUNCTION. THIS IS THE MECHANICAL COMPLICATION AS WELL AS THE DISPLACEMENT OF HIS IMPLANT. AT THIS POINT, THE SURGEON AND PATIENT AGREED THAT IT WOULD BENEFIT THE PATIENT TO REMOVE AND REPLACE THE IMPLANT. IT WAS DISCUSSED PLACING HIS PUMP MORE POSTERIORLY AS THE PUMP RUBS AGAINST HIS CLOTHES AND GYM WEAR AND IS VERY SENSITIVE. DURING SURGERY IT WAS NOTED THERE WAS A SLIGHT OPENING IN THE RIGHT CORPORA INDICATING THE SITE OF THE ANEURYSM. THIS TISSUE WAS SOMEWHAT TINNED OUT AS WELL. THIS REPORT CAPTURES THE ANEURYSMAL DEFECT AND MECHANICAL COMPLICATION.

  Patient problems: Discomfort; Erosion

  MAUDE report 25046604 ↗
• InjuryApr 17, 2026Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A HOLE IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913146 ↗
• InjuryApr 17, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO AN EXIT TUBING TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912120 ↗
• MalfunctionMar 25, 2026Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, WHILE USING THE PUSHER TO PUSH CYLINDER DOWN PROXIMALLY, PART OF THE MATERIAL OF THE CYLINDER AROUND THE TUBING SNAPPED [TORE]. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687567 ↗
• InjuryMar 23, 2026Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A LEAK IN THE CYLINDER TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664783 ↗
• InjuryMar 23, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO TORN [FRACTURED] TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663667 ↗
• MalfunctionMar 18, 2026Pumping Problem; Physical Resistance/Sticking

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTED THAT THE PUMP IS NOT PUMPING AND THE PUMP IS VERY STIFF TO INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631697 ↗
• InjuryMar 6, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO MALFUNCTION. ONE SIDE OF CORPORA WAS SHORTER THAN THE OTHER AND MADE THE CYLINDER BUNCH UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531100 ↗
• MalfunctionMar 2, 2026Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT REPORTED PUMP WAS INCORRECTLY PLACED TOO HIGH AND IS NOT ABLE TO BE MOVED DOWN. REVISION SURGERY UNSCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482410 ↗
• MalfunctionFeb 20, 2026Self-Activation or Keying

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT HAS STARTED AUTO INFLATING. A REVISION SURGERY IS SCHEDULED BUT HAS NOT YET BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406204 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED WITH A NARROW BASE INFLATABLE PENILE PROSTHESIS (TITAN) DUE TO EROSION.

  Patient problems: Erosion

  MAUDE report 24348644 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24296425 ↗
• InjuryJan 22, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153029 ↗
• InjuryJan 21, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION [FRACTURE] WITH THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130628 ↗
• InjuryJan 19, 2026Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A HOLE IN TUBING FROM CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109158 ↗
• InjuryJan 12, 2026Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO TUBING LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043401 ↗
• InjuryNov 20, 2025Adverse 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 IMPENDING EROSION AT THE TIP.

  Patient problems: Erosion

  MAUDE report 23606797 ↗
• InjuryNov 4, 2025Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS REVISED TO MOVE THE CYLINDERS AND REMOVE THE REAR TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465986 ↗
• InjuryOct 22, 2025Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361299 ↗
• InjurySep 25, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TEAR IN THE RESERVOIR TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143029 ↗
• InjurySep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010717 ↗

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

…and 2 more.