Titan ES8818Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 05708932487221), received between Jul 24, 2017 and Jun 1, 2026 — classified as 105 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN WAS REMOVED AND REPLACED WITH A MALLEABLE (GENESIS) DUE TO PATIENT BEING UNHAPPY WITH TUBING. THE TUBING WAS POORLY BURIED. THE TUBING WAS SUPERFICIAL AND CLUMPED TOGETHER BY CAPSULE, IT HAD NOTHING TO DO WITH PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354947 ↗
• InjuryMay 1, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO A TUBING CRACK [FRACTURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057166 ↗
• InjuryApr 16, 2026Device Appears to Trigger Rejection

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

  Patient problems: Erosion

  MAUDE report 24904602 ↗
• InjuryMar 20, 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 24654815 ↗
• InjuryJan 30, 2026Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS REMOVED AND REPLACED DUE TO TUBING EXIT LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221288 ↗
• InjuryJan 29, 2026Fluid/Blood Leak; Failure to Pump

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE DEVICE NOT PUMPING. THERE WAS NO SALINE LEFT IN THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209039 ↗
• InjuryJan 6, 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 23981636 ↗
• InjuryDec 2, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694988 ↗
• InjuryDec 2, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694170 ↗
• InjuryNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAK IN THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468664 ↗
• InjuryOct 22, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO EROSION/CROSSOVER.

  Patient problems: Erosion

  MAUDE report 23357917 ↗
• InjuryOct 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAK AT THE CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357602 ↗
• InjurySep 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO IT BEING OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100920 ↗
• InjuryJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205557 ↗
• InjuryMay 27, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A TUBING BREACH [FRACTURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088695 ↗
• InjuryMay 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO EROSION/EXTRUSION.

  Patient problems: Erosion

  MAUDE report 22027433 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO MW5170047: PATIENT HAD A PENILE PROSTHESIS IMPLANT IN 2019. LAST YEAR PATIENT WAS DIAGNOSED WITH A FAULTY PENILE PUMP WITH PUMP EROSION. THERE ARE TWO CYLINDERS IN THE PUMP AND ONE CYLINDER IS PUSHING OUT AGAINST THE PATIENT'S SKIN. THE ISSUE FLARES UP ONCE THE PUMP IS INFLATED. PATIENT STATES THE PROSTHESIS IS A RECALLED DEVICE. RECALL STATUS WAS ESTABLISHED (B)(6) 2021. RECALL NUMBER IS Z04882021. PATIENT STATES THE MANUFACTURER FAILED THEIR OBLIGATION TO NOTIFY ALL PATIENTS. PATIENT PERCEIVES THAT THE DEVICE COULD HAVE BEEN FAULTY FROM THE START WITH AN EXPIRATION/USED BY DATE OF JULY 8, 2024. SINCE 2024, PATIENT HAS BEEN SEEN BY DOCTOR AND PATIENT IS HAVING A REVISION SURGERY WHERE THE IMPLANT IS BEING REPLACED BY A BOSTON SCIENTIFIC PROSTHESIS. PATIENT HAS HYPERTENSION, HYPOTHYROIDISM, ANXIETY, AND POST-TRAUMATIC STRESS DISORDER. PATIENT ALSO HAS PROSTATE CANCER IN REMISSION AND HAD PROSTATE REMOVED IN 2024.

  Patient problems: Anxiety; Distress; Erosion

  MAUDE report 22004938 ↗
• InjuryMay 5, 2025Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960389 ↗
• InjuryApr 24, 2025Collapse; Collapse

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901006 ↗
• InjuryApr 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848922 ↗
• InjuryMar 10, 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 EROSION.

  Patient problems: Erosion

  MAUDE report 21559847 ↗
• InjuryMar 6, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED DUE TO TUBING BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537100 ↗
• InjuryFeb 26, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAS EXPRESSED SIGNIFICANT CONCERN REGARDING THE PROCEDURE, AS IT APPEARS THAT THE PENILE IMPLANT WAS NOT CORRECTLY PLACED DURING THE INITIAL SURGERY AND IS NOW BROKEN INSIDE HIS BODY. THIS ISSUE HAS CAUSED THE PATIENT DISCOMFORT AND DISTRESS. THE PATIENT HAD THE FIRST SURGERY [IMPLANT] IN (B)(6) 2024 IN WHICH THE DOCTOR PLACED THE RESERVOIR UNDER HIS SKIN INSTEAD OF PLACING IT UNDER HIS STOMACH MUSCLES. THE PATIENT'S STOMACH REPORTEDLY STARTED GETTING BIGGER, THEREFORE HE REQUESTED TO HAVE ANOTHER SURGERY. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) TO REPOSITION THE RESERVOIR; HOWEVER, AFTER THAT SURGERY THE DEVICE HAS NOT BEEN WORKING. A SCAN SHOWED THAT THE DEVICE HAD BUSTED [BROKEN] INSIDE HIS BODY AND THE PATIENT STATED THAT FLUID IS LEAKING UNDER HIS BODY NOW. HE HAS ALSO DEVELOPED SEROMA WHICH IS MAKING HIM UNCOMFORTABLE. THE PHYSICIAN HAS REPORTEDLY ADVISED THE PATIENT TO "SIT TIGHT AND BE CAREFUL" UNTIL A REVISION SURGERY CAN BE PERFORMED.

  Patient problems: Discomfort; Distress; Pain; Seroma

  MAUDE report 21473612 ↗
• InjuryFeb 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE SYSTEM BEING DIFFICULT TO PUMP. IT WAS ALSO NOTED THAT THE PUMP WAS 11 YEARS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432638 ↗
• InjuryFeb 7, 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 THE IMPLANTED CYLINDER WAS NOT LONG ENOUGH TO REACH THE DISTAL END OF PENIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334524 ↗

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-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; 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-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; 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-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; 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-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis

…and 3 more.