Titan Classic ES8924Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05708932768139), received between Mar 27, 2025 and Jun 23, 2026 — classified as 6 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25598628 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25448492 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS. THERE IS NO INDICATION IF ONLY A SINGLE CYLINDER WAS PLACED OR IF A CYLINDER WAS REMOVED AT A LATER DATE; HOWEVER, ON (B)(6) 2026 THE PATIENT ONLY HAD 1 CYLINDER, SO ANOTHER CYLINDER WAS PLACED. THE ASSUMPTION FROM THE FIELD IS THEY BELIEVE THE PATIENT HAD ONLY 1 CYLINDER DUE TO A PERFORATION EITHER DURING THE IMPLANT SURGERY OR AT A LATER DATE THAT CAUSED REMOVAL OF A SINGLE CYLINDER.

  Patient problems: Perforation

  MAUDE report 25112664 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO PATIENT DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 24640073 ↗
• MalfunctionFeb 23, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING OF A 24CM PRECONNECT HAD TO BE TRIMMED AS IT WAS TOO LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421704 ↗
• MalfunctionFeb 20, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION PATIENT WAS MEASURED 24CM. PHYSICIAN ENDED UP USING 22 + 2CM REAR TIP EXTENDER (RTE) INSTEAD OF THE PRE-CONNECT DEVICE BECAUSE THE 24CM TUBING IS TOO LONG. IDEALLY, WOULD HAVE LIKED TO AVOID PUTTING ON RTES BUT SURGEON DID NOT WANT TO TRIM ALL THREE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404949 ↗
• MalfunctionFeb 18, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR WILL ONLY USE THE PRECONNECT IF THE PATIENT HAS AN INCREDIBLY LARGE SCROTUM AS THE TUBING LENGTH IS WAY TOO LONG. THE DOCTOR HAS USED IT A COUPLE OF TIMES WITH PATIENTS WITH LARGE SCROTUMS AND HE STILL HAD TO TRIM THE TUBING LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381622 ↗
• MalfunctionFeb 18, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR WILL ONLY USE THE PRECONNECT IF THE PATIENT HAS AN INCREDIBLY LARGE SCROTUM AS THE TUBING LENGTH IS WAY TOO LONG. THE DOCTOR HAS USED IT A COUPLE OF TIMES WITH PATIENTS WITH LARGE SCROTUMS AND HE STILL HAD TO TRIM THE TUBING LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380919 ↗
• MalfunctionFeb 18, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR HAS CHOSEN NOT TO USE THE PRECONNECT BECAUSE OF THE TUBING LENGTH. HE WILL ONLY USE IT IF THE PATIENT HAS AN INCREDIBLY LARGE SCROTUM. THE TUBING LENGTH IS WAY TOO LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380095 ↗
• MalfunctionFeb 4, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE TUBING IS FAR TOO LONG. THE PHYSICIAN HAD TO CUT OFF TUBING AND MAKE FURTHER CONNECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257680 ↗
• MalfunctionFeb 4, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE TUBING IS FAR TOO LONG. THE PHYSICIAN HAD TO CUT OFF TUBING AND MAKE FURTHER CONNECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257628 ↗
• MalfunctionJan 6, 2026Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION THE PRE-CONNECT 24CM SCROTAL TUBING HAD TO BE TRIMMED BY 5CM PRIOR TO BEING IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974917 ↗
• MalfunctionDec 31, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE TUBING ON THE NEW 24 CM PRECONNECT IMPLANT WAS 2.75 CM TOO LONG. PHYSICIAN TRIMMED AND RECONNECTED TUBING FROM PUMP TO CYLINDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937012 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED WITH A MALLEABLE DUE TO PAIN IN SCROTAL AREA. IT WAS NOTED TO BE A POSSIBLE INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23605477 ↗
• MalfunctionNov 4, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION DURING THE IMPLANT PROCEDURE, 6.5CM OF PUMP TUBING HAD TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465940 ↗
• MalfunctionOct 20, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PRE-CONNECTED 24CM TUBING NEEDED TO BE TRIMMED DURING IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336174 ↗
• InjurySep 18, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION THREE WEEKS AFTER RECEIVING THE IMPLANT, THE PATIENT WENT TO SEE THE IMPLANTING DOCTOR TO LEARN HOW TO START INFLATING HIS IMPLANT. THE IMPLANT WORKED FINE AND FOUR DAYS LATER, THE PATIENT TRIED TO INFLATE THE IMPLANT AND THE BULB WENT FLAT. THE IMPLANT DOCTOR ORDERED AN MRI AND THE RESULTS SHOWED THE FLUID HAD LEAKED. PATIENT UNDERWENT REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088995 ↗
• MalfunctionSep 9, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO AVAILABLE INFORMATION, PHYSICIAN USED THEIR FIRST 24 RECONNECTED DEVICE. THE PATIENT MEASURED 14 DISTALLY AND 11 PROXIMALLY. THE PHYSICIAN USED A 24CM IMPLANT WITH 1CM REAR TIP EXTENDERS. PHYSICIAN ENDED UP NEEDING TO TRIM 2.9CM OFF ONE SIDE OF THE TUBING AND 2.4CM OFF THE OTHER. HE FEELS LIKE THE TUBING IS TOO LONG AND WILL CONTINUE TO USE NON-PRECONNECTED AS LONG AS IT REMAINS AVAILABLE OR UNTIL THE PRECONNECTED TUBING IS SHORTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006445 ↗
• MalfunctionAug 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR PLACED A 24 PRE-CONNECT TITAN DEVICE AND UNFORTUNATELY HAD TO SHORTEN THE TUBING. THE PATIENT HAD A 12CM PROXIMAL MEASUREMENT, SO NOT SHALLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915704 ↗
• MalfunctionJul 15, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, 4 CM WAS TRIMMED OFF OF THE TUBING DURING THE IMPLANT OF THE 24 CM PRE-CONNECT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22508453 ↗
• MalfunctionMay 22, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANTING PHYSICIAN NOTED THAT THE TUBING ON THE 24 CM PRE-CONNECT DEVICE 'WAS A BIT LONG.' THE PHYSICIAN INDICATED HE FELT IT WAS A LITTLE TOO LONG FOR THE PATIENT THAT HE IMPLANTED LAST WEEK. HE WAS ABLE TO TACK THE TUBING POSTERIOR AS TO AVOID THE TUBING FROM BUNCHING UP OR PROTRUDING IN THE SCROTUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069707 ↗
• MalfunctionApr 4, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS AN ISSUE WITH THE TUBING LENGTH FOR THE 24 PRE CONNECT DEVICE. THE TUBING WAS TOO LONG AND NEEDED TO TRIM DOWN TO GET TO THE CORRECT LENGTH FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21779724 ↗
• MalfunctionMar 27, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT MEASURED 13 PROXIMAL AND 11 DISTAL. ONCE THE SURGEON PLACED THE PUMP OF THE PRE-CONNECT, HE DID MAKE THE COMMENT IF THE PROXIMAL MEASUREMENT HAD BEEN LESS THAN 13, OR OF THE PATIENT¿S SCROTUM WERE A BIT SMALLER, HE WOULD MORE THAN LIKELY HAVE NEEDED TO TRIM THE TUBING AS THE PATIENT WOULD MORE THAN LIKELY EXPERIENCE REDUNDANT TUBING WHICH MAY BE PALPABLE AND/OR VISIBLE. AFTER THE PATIENT INCISION WAS CLOSED AND THE DEVICE WAS INFLATED, THE SURGEON DID NOTE THE TUBING WAS A BIT PALPABLE AT THE BASE OF THE SCROTUM. IT WASN'T CLEAR TO HIM AT THIS POINT IF THE TUBING HE FELT WOULD BE AN ISSUE WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708928 ↗
• MalfunctionMar 27, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE DOCTOR OPTED TO NOT USE THE 24CM PRE-CONNECT. THE PATIENT HAD A PROXIMAL MEASUREMENT OF 13CM AND A DISTAL MEASUREMENT OF 14CM FOR A TOTAL OF 27CM. THE PATIENT HAD A PREVIOUS IMPLANT WHICH WAS 22CM + 3CM RTE. IN THIS CASE, THE DOCTOR MADE THE DECISION TO STAY WITH THE 25CM MEASUREMENT. FOR THIS PATIENT, THE DOCTOR WAS CONCERNED THE TUBING LENGTH FOR THE 24CM WOULD HAVE BEEN TOO LONG AND OPTED TO USE 22CM + 3CM RTE. THE DOCTOR DOES NOT LIKE TO MAKE EXTRA CONNECTIONS AND REALLY DID NOT WANT TO TAKE THE CHANCE HE WOULD NEED TO TRIM THE TUBING ON THE 24CM PRE-CONNECT THEN RE-CONNECT THE PUMP TO THE CYLINDERS. THERE WERE NO ISSUES WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708303 ↗

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-1360-2023 · Mar 1, 2023 · Open, Classified
  Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
• Z-1361-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
• Z-1363-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
• Z-1370-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
• Z-1371-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
• Z-1369-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; 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-1364-2023 · Mar 1, 2023 · Open, Classified
  Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
• Z-1365-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
• Z-1366-2023 · Mar 1, 2023 · Open, Classified
  Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
• Z-1373-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; 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-1375-2023 · Mar 1, 2023 · Open, Classified
  Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis

…and 3 more.