Titan ES8920Recalls & reported problems

Summary

The FDA's MAUDE database contains 476 adverse event reports that list this exact device (DI 05708932487368), received between Aug 16, 2017 and Jul 9, 2026 — classified as 401 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Fracture” (89 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

   XXX

   Z-1374-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 476 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTS A MAJOR CONCERN RELATED TO THE PRESENCE OF VISIBLE AND PALPABLE ¿DOG EARS¿ OR ABNORMAL PROTRUSIONS AFFECTING THE COSMETIC APPEARANCE OF THE PENIS FOLLOWING IMPLANTATION. WHILE ERECTILE RIGIDITY MAY HAVE BEEN RESTORED, THE COSMETIC IRREGULARITIES NEGATIVELY AFFECT SELF-IMAGE, COMFORT, AND SEXUAL CONFIDENCE. PATIENT BELIEVES THAT MORE ATTENTION SHOULD BE DIRECTED TOWARD POST-OPERATIVE PENILE AESTHETICS AND NOT SOLELY TOWARD ERECTILE MECHANICS.

  Patient problems: Deformity/ Disfigurement; Discomfort; Emotional Changes

  MAUDE report 25770256 ↗
• MalfunctionJul 9, 2026Patient-Device Incompatibility; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTS THAT OPERATION OF THE PUMP MECHANISM REQUIRES SIGNIFICANT EFFORT AND OFTEN NECESSITATES THE USE OF BOTH HANDS. THIS CREATES PRACTICAL DIFFICULTIES DURING INTIMATE SITUATIONS AND DIMINISHES SPONTANEITY. THE PATIENT EXPECTED THAT, AFTER RECOVERY, INTIMACY WOULD FEEL MORE NATURAL AND DISCREET. INSTEAD, ACTIVATION OF THE DEVICE FREQUENTLY BECOMES A PHYSICALLY DELIBERATE AND PSYCHOLOGICALLY DISTRACTING PROCESS.

  Patient problems: Emotional Changes

  MAUDE report 25770225 ↗
• MalfunctionJun 26, 2026Self-Activation or Keying

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTS HE IS EXPERIENCING AUTO INFLATION. HIS UROLOGIST INSTRUCTED HIM TO INFLATE/DEFLATE HIS DEVICE SEVERAL TIMES A DAY TO HELP THE VALVE REPAIR ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643038 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, TITAN IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25638484 ↗
• InjuryJun 26, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZE. NO PRODUCT PROBLEM OR ISSUE. PATIENT WANTED DIFFERENT SIZE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638224 ↗
• InjuryJun 23, 2026Inflation Problem; Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A MALFUNCTION OF THE LEFT CYLINDER. THERE WAS A SMALL TEAR IN THE BIOFLEX MATERIAL THAT WAS CAUSING THE DEVICE TO NOT FILL PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594645 ↗
• InjuryJun 1, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348590 ↗
• InjuryApr 17, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN UNSPECIFIED MALFUNCTION. IT WAS NOTED THAT THE DEVICE WAS AROUND 10 YEARS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911806 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED WITH A GENESIS DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24899487 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED WITH A MALLEABLE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24895954 ↗
• InjuryApr 10, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING AND EROSION.

  Patient problems: Erosion

  MAUDE report 24845194 ↗
• MalfunctionApr 9, 2026Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, A CYLINDER ANEURYSM OCCURRED DURING MODELING. A NEW IMPLANT WAS SUCCESSFULLY USED AND IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835917 ↗
• InjuryApr 3, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO TUBING DEFECT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776108 ↗
• MalfunctionMar 30, 2026Inflation Problem; Physical Resistance/Sticking

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT REPORTED THAT THE IMPLANT IS NOT WORKING. AFTER THREE PUMPS ON THE IMPLANT BULB, THE DEVICE [PUMP] STAYS FIRM AND CANNOT PUMP ANY FURTHER. AN EVALUATION APPOINTMENT HAS BEEN SCHEDULED BUT NOT YET COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728368 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24701810 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT WAS REMOVED AND REPLACED WITH A GENESIS AS THE TUBING FROM THE PUMP TO THE RESERVOIR WENT THROUGH THE SKIN "[EROSION]".

  Patient problems: Erosion

  MAUDE report 24699903 ↗
• InjuryMar 23, 2026Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO FLUID LEAKING. IT WAS NOTED THAT THE IMPLANT WAS 13-YEARS-OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669417 ↗
• InjuryMar 23, 2026Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED WITH A GENESIS DUE TO A POSITIONING ISSUE RELATED TO OTHER SURGERIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661348 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO EROSION.

  Patient problems: Erosion

  MAUDE report 24611555 ↗
• InjuryMar 4, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO INCORRECT SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505692 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED WITH A GENESIS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24495613 ↗
• MalfunctionFeb 27, 2026Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, A CYLINDER ANEURYSM OCCURRED DURING MODELING. A NEW IMPLANT WAS SUCCESSFULLY USED AND IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475543 ↗
• MalfunctionFeb 24, 2026Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, A MALFUNCTION OF THE CYLINDER [ANEURYSM] OCCURRED DURING MODELING. ANOTHER CYLINDER/PUMP SET WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435948 ↗
• InjuryFeb 24, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431050 ↗
• InjuryFeb 23, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO A TUBING BREAK OF THE PUMP/RESERVOIR TUBE WHERE IT MEETS THE PUMP. DEVICE WAS OVER 10 YEARS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416832 ↗

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-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• 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-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-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis

…and 2 more.