Titan 519310Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05701780277006), received between May 2, 2024 and Jun 27, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Inadequacy of Device Shape and/or Size; Device Misassembled During Manufacturing /Shipping; Inadequacy of Device Shape and/or Size; Device Misassembled During Manufacturing /Shipping

  ACCORDING TO THE AVAILABLE INFORMATION, THE REAR TIP EXTENDERS DID NOT MATCH THE SIZE WRITTEN IN THE BOTTOM OF EACH [PACKAGING] WELL. THE SCRUB TECH READ THE BOTTOM OF THE WELL AND ATTACHED THE WRONG SIZE TIPS. THE PHYSICIAN CAUGHT THE ERROR AND REPLACED THEM WITH THE CORRECT SIZE TIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345225 ↗
• InjuryDec 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, A REVISION SURGERY WAS PERFORMED TO REMOVE THE 1 CM REAR TIP EXTENDER (RTE) FROM THE LEFT CYLINDER AND REPLACE IT WITH A 2 CM RTE. A GRAFT WAS USED TO CLOSE THE IMPLANT AS THE PATIENT WAS VERY FIBROTIC AND THE TISSUE WAS NOT AS PLAYABLE AS THE PHYSICIAN WOULD HAVE LIKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868840 ↗
• InjuryAug 26, 2024Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION, THE RIGHT CYLINDER REAR TIP EXTENDER MIGRATED. RIGHT REAR TIP EXTENDER REMOVED AND REPLACED WITH NEW 1CM REAR TIP EXTENDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071268 ↗
• MalfunctionJul 8, 2024Contamination; Contamination

  ACCORDING TO THE AVAILABLE INFORMATION THE REAR TIP EXTENDER KIT WAS FOUND WITH A FOREIGN OBJECT INSIDE THE STERILE PACKAGING. THE DEVICE WAS IMMEDIATELY TAKEN OFF THE FIELD AND NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690019 ↗
• MalfunctionMay 2, 2024Break; Break

  ACCORDING TO THE AVAILABLE INFORMATION, THE REAR TIP EXTENDER BROKE WHEN TRYING TO RESIZE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19232183 ↗

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-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-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; 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-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1362-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
• Z-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1367-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1374-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

…and 3 more.