Titan 90-9000KCRecalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 05708932319621), received between Jul 24, 2017 and Jul 9, 2026 — classified as 114 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fracture” (42 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-1360-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Material Frayed

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO THE PUMP TUBING WAS FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765535 ↗
• MalfunctionJun 30, 2026Inflation Problem; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT PREVIOUSLY HAD A REVISION ON THE PUMP. NOW POST REVISION, THE PATIENT SAYS HIS DEVICE INFLATES TO ABOUT 98% OF FIRMNESS OF WHAT HE ACHIEVED BEFORE THE REVISION WITH THE FAULTY PUMP, AS WELL AS WHAT HE PERCEIVES A 1 CM LOSS OF LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664747 ↗
• InjuryApr 22, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959913 ↗
• InjuryApr 22, 2026Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS REMOVED AND REPLACED DUE TO A PUMP-RESERVOIR TUBING FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958113 ↗
• InjuryApr 22, 2026Physical Resistance/Sticking

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT REMOVED AND REPLACED DUE TO THE PUMP STICKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955560 ↗
• InjuryApr 17, 2026Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANTED TITAN RIGHT CYLINDER WAS REPLACED DUE TO AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911314 ↗
• InjuryDec 8, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2026 DUE TO A BREAK IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743984 ↗
• InjuryNov 26, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656491 ↗
• InjuryNov 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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23596730 ↗
• InjuryNov 11, 2025Fracture; Pumping Problem; Fracture; Pumping Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE DEVICE NOT WORKING WHEN PUMPING. INTRAOPERATIVELY IT WAS IDENTIFIED THERE WAS BROKEN (BLACK RESERVOIR) TUBING ADJACENT TO THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522583 ↗
• InjuryOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437322 ↗
• InjuryOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LOSS OF FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390087 ↗
• InjuryMay 30, 2025Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, THE PUMP WAS EXPLANTED AND REPLACED DUE TO BEING FLIPPED UPSIDE DOWN [MIGRATED].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114563 ↗
• InjuryMay 27, 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 SIZE ISSUE. THE PATIENT ALSO HAD PAIN AT HIS TIPS.

  Patient problems: Pain

  MAUDE report 22087575 ↗
• MalfunctionMay 16, 2025Failure to Pump; Failure to Pump

  ACCORDING TO THE AVAILABLE INFORMATION, THE INFLATION/DEFLATION BULB WENT FLAT ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036543 ↗
• InjuryMay 6, 2025Malposition of Device; Malposition of Device

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO POOR PLACEMENT OF PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971393 ↗
• InjuryMay 1, 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 21942578 ↗
• InjuryApr 23, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO FLUID LOSS CAUSED BY A TUBING MALFUNCTION [FRACTURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895388 ↗
• MalfunctionMar 26, 2025Self-Activation or Keying; Self-Activation or Keying

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE HAS BEEN IMPLANTED FOR ABOUT 3 YEARS. REPORTEDLY, ON MEDIUM PRESSURE INFLATION, THE PUMP SEAMS TO RESONATE AGAINST THE CHECK VALVE AND PUMPS FLUID BACK INTO THE RESERVOIR [AUTO DEFLATION]. THE PATIENT CAN DISTINCTLY FEEL THE RESONANCE ALL THE WAY TO THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699303 ↗
• InjuryMar 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632325 ↗
• InjuryFeb 28, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21496900 ↗
• InjuryFeb 28, 2025Failure to Pump; Failure to Pump

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE AS THE IMPLANT WOULD NOT PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21492400 ↗
• InjuryFeb 19, 2025Failure to Pump; Failure to Pump

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE PUMP COLLAPSING AND NOT PUMPING BUT NO LEAK COULD BE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412142 ↗
• InjuryJan 22, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208590 ↗
• InjuryJan 6, 2025Material Puncture/Hole; Connection Problem; Material Puncture/Hole; Connection Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A HOLE IN THE SYSTEM AND AN ALLEGED ISSUE WITH THE CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085160 ↗

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-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
• Z-1359-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
• Z-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; 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-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1368-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1372-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; 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.