Titan ES8922Recalls & reported problems

Summary

The FDA's MAUDE database contains 334 adverse event reports that list this exact device (DI 05708932487382), received between Oct 19, 2017 and Jun 23, 2026 — classified as 280 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Fracture” (78 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-1375-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 334 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 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 AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25597652 ↗
• InjuryJun 17, 2026Fluid/Blood Leak; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT UNDERWENT A REVISION PROCEDURE ABOUT 11 MONTHS AFTER HIS ORIGINAL IMPLANT. HE STATED THE IMPLANT WAS NO LONGER INFLATING AND BELIEVES IT LOST ALL SALINE FLUID. THERE WAS NO KNOWN INFECTION PRESENT OR FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534478 ↗
• InjuryJun 11, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO SIZING, WANTED LARGER CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477918 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448588 ↗
• InjuryMay 29, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331850 ↗
• InjuryMay 29, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING BREAK RIGHT ABOVE THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331319 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED. DURING THE REVISION A PREVIOUS PERFORATION ON LEFT SIDE WAS IDENTIFIED.

  Patient problems: Perforation

  MAUDE report 25317082 ↗
• InjuryMay 28, 2026Deflation Problem; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT WAS REMOVED AND REPLACED DUE TO HARD TO INFLATE AND DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316728 ↗
• InjuryMay 26, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A VISIBLE CRACK IN THE TUBING FROM CYLINDER TO PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25282204 ↗
• InjuryMay 12, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE LEFT CYLINDER WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152715 ↗
• MalfunctionMay 12, 2026Difficult to Insert; Air/Gas in Device

  ACCORDING TO THE AVAILABLE INFORMATION, DURING THE CASE THEY PREPPED A 22CM TITAN SCROTAL. WHEN THEY PREPPED THE IMPLANT, EVERYTHING WAS FINE. THEY WERE HAVING A DIFFICULT TIME PLACING THE PROXIMAL PORTION OF THE IMPLANT AS WELL AS THE PUMP DURING THE CASE. THEY WERE FINALLY ABLE TO MOVE FORWARD, AS THE SURGEON PREPARED TO PLACE THE PUMP HE REALIZED THERE WAS AN AIR BUBBLE IN THE PUMP. THEY CYCLED THE IMPLANT AGAIN AND THE AIR BUBBLE WAS CLEARED. AS THEY PREPARED TO PLACE THE PUMP AGAIN, HE NOTICED THE PUMP FELT DECOMPRESSED. THEY INITIALLY THOUGHT IT WAS DUE TO A BAD RUBBER SHOD SO THEY SWITCHED TO A NEW RUBBER SHOD AFTER CLEARING THE BUBBLE AGAIN. WHEN THE PHYSICIAN PLACED THE PUMP IN THE SCROTUM, HE NOTICED THE PUMP WAS DECOMPRESSED AGAIN. THEY REMOVED THE ENTIRE IMPLANT FROM THE CORPORA AND PERFORMED A TEST TO ENSURE THERE WAS NO LEAK IN THE SYSTEM. THERE WASN'T ANYTHING VISIBLE BUT AT THAT POINT THE PHYSICIAN DID NOT FEEL COMFORTABLE SINCE THEY COULD NOT UNDERSTAND WHY THAT OCCURRED. THE PHYSICIAN MENTIONED THAT HE WAS VERY FORCEFUL WITH THE PUMP WHEN PLACING IT IN THE SCROTUM AND WONDERED IF THAT COULD HAVE CONTRIBUTED TO THE ISSUE. THE PHYSICIAN DECIDED IT WOULD BE BEST TO R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148867 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE PHYSICIAN DEPLOYED THE CYLINDER INTO THE CORPORA, THE CYLINDER OUTSIDE THE BODY FILLED UP WITH BLOODY LIQUID. THIS IMPLANT WAS REMOVED FROM THE BODY. IT SHOWED A HOLE DISTALLY ON THE IMPLANT CAUSING LIQUID TO ESCAPE. ANOTHER IMPLANT WAS OPENED AND USED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143638 ↗
• InjuryMay 11, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO INCORRECT SIZING: TOO SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135637 ↗
• InjuryMay 5, 2026Self-Activation or Keying

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REMOVED AND REPLACED DUE TO AN AUTO INFLATION MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081491 ↗
• InjuryMay 4, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068083 ↗
• InjuryApr 23, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967219 ↗
• InjuryApr 22, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, CYLINDERS REMOVED AND REPLACED DUE TO A TUBING BREAK [FRACTURE] ON THE LEFT CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955765 ↗
• InjuryApr 21, 2026Crack

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS EXPLANTED AND REPLACED DUE TO A CRACK AT THE TOP OF PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940065 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24932532 ↗
• InjuryApr 20, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS EXPLANTED AND REPLACED DUE TO BROKEN TUBING AT THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927562 ↗
• InjuryApr 17, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912874 ↗
• InjuryApr 16, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BROKEN TUBING AT THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903781 ↗
• InjuryApr 16, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO UNKNOWN REASONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899762 ↗
• InjuryApr 14, 2026Migration

  ACCORDING TO THE AVAILABLE INFORMATION THE IMPLANT WAS REMOVED AND REPLACED DUE TO LEFT CYLINDER MIGRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873539 ↗
• InjuryMar 9, 2026Fracture; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO HOLE AND LEAK IN TUBING TO CYLINDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544509 ↗

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-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; 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-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

…and 2 more.