Titan ES8918Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 05708932487344), received between Jul 25, 2017 and Jun 24, 2026 — classified as 210 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (38 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-1373-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 225 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Device Appears to Trigger Rejection

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

  Patient problems: Erosion

  MAUDE report 25608752 ↗
• 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: Unspecified Infection

  MAUDE report 25448029 ↗
• InjuryMay 20, 2026Inadequacy of Device Shape and/or Size; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT PUMP REMOVED AND REPLACED DUE TO THE PATIENT HAVING TROUBLE USING THE PUMP WHERE IT WAS LOCATED IN THE SCROTUM. NOTHING WAS WRONG WITH THE PUMP, OTHER THAN LOCATION. THE PUMP WAS MISPOSITIONED, MAINLY DUE TO THE LACK OF TUBING LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230118 ↗
• InjuryApr 30, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO A CRACK AT TUBING PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050275 ↗
• InjuryApr 21, 2026Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945885 ↗
• InjuryApr 7, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE TITAN IMPLANT WAS REPLACED WITH A MALLEABLE (GENESIS) DUE TO AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806800 ↗
• InjuryJan 20, 2026Adverse 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 24117844 ↗
• InjuryJan 9, 2026Fracture; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS NOT FILLING WHEN THE PATIENT WAS PUMPING. THE IMPLANT WAS REMOVED AND REPLACED, AND IT WAS NOTED THERE WAS BROKEN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027052 ↗
• InjuryJan 7, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989460 ↗
• InjuryDec 19, 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 23849358 ↗
• InjuryDec 18, 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 23838362 ↗
• InjuryOct 23, 2025Material Frayed; Material Frayed

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE CYLINDER TUBING BEING FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366927 ↗
• InjuryOct 21, 2025Fracture; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A TUBING TEAR APPROXIMATELY 2 INCHES FROM THE PUMP, CONNECTING TO THE CYLINDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348953 ↗
• InjuryAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THERE NOT BEING ANY FLUID IN THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773527 ↗
• InjuryJul 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO FURTHER INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523491 ↗
• InjuryJul 7, 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 WITH A MALLEABLE DUE TO INFECTION AND PUSS FOUND OUTSIDE OF THE CORPORA. THE IMPLANT WAS OUTSIDE OF THE CORPORA BODY [EROSION].

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 22421964 ↗
• MalfunctionJun 27, 2025Failure to Deflate; Failure to Deflate

  ACCORDING TO THE AVAILABLE INFORMATION DURING THE IMPLANT PROCEDURE, ONE OF THE CYLINDERS WOULD NOT DRAIN DURING THE DRAINING PROCESS. THE CYLINDERS WERE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350406 ↗
• InjuryApr 25, 2025Material Puncture/Hole; Material 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 21910958 ↗
• InjuryApr 25, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, DURING CLOSURE, THE CYLINDER WAS PUNCTURED. THE IMPLANT LEAKED OVER TIME. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910422 ↗
• InjuryApr 24, 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 AS THE INCISION HAD OPENED AFTER THE ORIGINAL IMPLANT AND THE PUMP WAS PREVIOUSLY REMOVED.

  Patient problems: Wound Dehiscence

  MAUDE report 21901441 ↗
• InjuryApr 1, 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 DUE TO PENDING EROSION. THE CYLINDER WAS NOT REPLACED.

  Patient problems: Erosion

  MAUDE report 21739448 ↗
• InjuryMar 6, 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 21536080 ↗
• InjuryFeb 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Erosion

  MAUDE report 21432494 ↗
• InjuryFeb 7, 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21334179 ↗
• InjuryJan 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO ADDITIONAL INFORMATION, THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON AND A MALLEABLE WAS IMPLANTED AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265994 ↗

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-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; 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-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; 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
• 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-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

…and 2 more.