AMS 700™ TENACIO™ Pump 72404429Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00191506021306), received between Sep 13, 2024 and Aug 21, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379353 ↗
• InjuryJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY SINCE IMPLANTATION. THE PATIENT STATED THAT THE IPP HAD ALREADY BEEN REMOVED. THE PATIENT WAS ADVISED TO FOLLOW UP WITH A PHYSICIAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461006 ↗
• InjuryFeb 12, 2026Inflation Problem; Mechanical Problem

  A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) REPORTED DIFFICULTY INFLATING THE PUMP. THE CLINIC ALSO NOTED THAT THEY WERE UNABLE TO GET THE DEVICE TO FUNCTION PROPERLY. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN REPLACED THE TENACIO PUMP WITH AN MS PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327777 ↗
• InjuryJan 19, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AN INFLATION PROBLEM AND AUTO INFLATION. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111849 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN EROSION OF THE PUMP THROUGH THE SCROTAL SKIN. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 23812458 ↗
• InjuryNov 17, 2025Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING FLUID LOSS. DURING EVALUATION, IT WAS FOUND THAT THE QUICK-CONNECT FITTING HAD BECOME DISCONNECTED AT ONE OF THE CONNECTIONS BETWEEN THE PUMP AND THE CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH ALL THE SYSTEM WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568747 ↗
• InjuryNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT REVISION SURGERY. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT CYLINDERS HAD A LEAK AT THE PROXIMAL END. THE ENTIRE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537951 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS PRESENTED WITH AN INFECTION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THE INFECTION AT THE SITE OF CLOSURE. THE DEVICE WAS REMOVED AND REPLACED WITH A MALLEABLE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 21967266 ↗
• InjurySep 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DID NOT LIKE THE TENACIO PUMP CONNECTED TO HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE BECAUSE HE FELT IT WAS HARD TO GRIP AND SLIPPERY. THE IPP CYLINDERS AND PUMP WERE EXPLANTED, AND A NEW SET OF PRECONNECTED CYLINDERS AND PUMP WERE CONNECTED TO THE EXISTING RESERVOIR. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217364 ↗