Titan ES8822Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 05708932487269), received between Jul 24, 2017 and Jun 17, 2026 — classified as 128 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (28 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 25 most recent of 151 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO IT NOT WORKING. THE PRODUCT WAS DISCARDED BEFORE IT WAS DETERMINED WHAT WAS WRONG, HOWEVER, THERE WAS NO BREAKAGE NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537156 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25473120 ↗
• InjuryJun 9, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448073 ↗
• InjuryMay 22, 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 25255529 ↗
• InjuryApr 24, 2026Inadequacy of Device Shape and/or Size

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984154 ↗
• InjuryApr 7, 2026Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT WAS REMOVED AND REPLACED WITH A TITAN TOUCH AS IT WAS NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806167 ↗
• InjuryMar 25, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687415 ↗
• InjuryMar 16, 2026Inadequacy of Device Shape and/or Size

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605362 ↗
• InjuryFeb 5, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272379 ↗
• InjuryJan 23, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING EXIT [BREAK] ON THE LEFT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164782 ↗
• InjuryDec 9, 2025Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AS THE PUMP WOULD NOT DEFLATE DUE TO SCAR TISSUE.

  Patient problems: Impaired Healing

  MAUDE report 23757788 ↗
• InjuryDec 5, 2025Inflation Problem; Pumping Problem; Inflation Problem; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED AS THE PUMP WOULD BE SOFT AND TAKE MANY PUMPS TO INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732258 ↗
• InjuryNov 12, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAK IN THE PUMP TUBING AND THE DEVICE NOT INFLATING AS THE PATIENT WOULD LIKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536236 ↗
• InjuryOct 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A RIGHT CYLINDER DISTAL LEAK AND RIGHT CYLINDER TUBING EXIT LEAK. THE DOCTOR STATES THAT PATIENT HAS NOT RECEIVED INJECTIONS FROM HIS OFFICE. THERE IS A SMALL PUNCTURE LEAK ON ONE CYLINDER DISTALLY. THIS WAS DISCOVERED ONCE THE CYLINDER WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336042 ↗
• InjuryOct 10, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23268524 ↗
• InjurySep 15, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052087 ↗
• InjuryAug 13, 2025Failure to Pump; Failure to Pump

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS EXPLANTED AND REPLACED DUE TO IT NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795151 ↗
• InjuryAug 11, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A HOLE IN THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776739 ↗
• InjuryMay 9, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, A REVISION WAS PERFORMED TO REPOSITION THE PUMP AND TUBING. THERE WAS NO REMOVAL OR REPLACEMENT OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997847 ↗
• InjuryMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, DURING A VIRGIN IMPLANT SURGERY, THERE WAS A LEAK IDENTIFIED IN THE CYLINDER AT THE CONCLUSION OF THE CASE. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993857 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE VALVE OF THE IMPLANT HAS "BUSTED" [FRACTURED], AND FLUID IS REPORTEDLY EVERYWHERE IN THE PATIENT'S BODY. THE PATIENT FEELS A LOT OF PAIN AND CAN HARDLY BEND OVER. THE PATIENT WENT TO THEIR SURGEON, BUT HE REFUSED THE PATIENT CARE. THE PATIENT HAS BEEN TO THE EMERGENCY ROOM, BUT THEY DIDN'T DO MUCH SINCE THEY DON'T HAVE MUCH INFORMATION ON THE IMPLANTS. THE PATIENT HAS SEEN A UROLOGIST THAT HAS ADVISED THE PATIENT TO HAVE THE IMPLANT REPLACED.

  Patient problems: Pain

  MAUDE report 21960000 ↗
• InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED AS THE IMPLANT WAS EXTRUDING OUT OF THE DISTAL END OF THE GLANS PENIS.

  Patient problems: Erosion

  MAUDE report 21900944 ↗
• InjuryApr 17, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT PUMP WAS REMOVED AND REPLACED DUE TO THE NEED TO REPOSITION THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860067 ↗
• MalfunctionApr 3, 2025Material Deformation; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, DURING A TEST INFLATION OF THE DEVICE, THE SURGEON DISCOVERED A CYLINDER ANEURYSM. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762685 ↗
• InjuryFeb 26, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO DUE TO THE PATIENT REQUESTING A DIFFERENT SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468899 ↗

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-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; 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-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; 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.