AMS 700™ CX TENACIO™ Pump 72404431Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00191506021320), received between Mar 20, 2025 and Sep 23, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 11, 2025Class IIOpen, Classified

   The potential for devices to experience inflation and/or deflation performance issues or difficulties.

   Z-0142-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Malposition of Device

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) stated the pump was positioned too posteriorly within the scrotum and could not be accessed. As a result, the device was explanted. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873895 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced pain associated with the implant. A surgical procedure was performed during which an infection in the scrotal area was identified. All components removed besides the reservoir. No additional patient complications were reported.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50255892 ↗
• InjuryMay 28, 2026Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE TENACIO PUMP WAS TOO HARD. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TENACIO PUMP AND REPLACE IT WITH AN MS PUMP. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326325 ↗
• InjuryMay 20, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH CYLINDER CROSSOVER. THE DEVICE WAS ABLE TO CYCLE BUT WAS NOT USABLE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING IPP WAS EXPLANTED AND REPLACED WITH TACTRA MALLEABLE PENILE PROSTHESIS CYLINDERS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25230338 ↗
• InjuryMay 14, 2026Unintended Deflation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED SPONTANEOUS DEFLATION AFTER INFLATION AND DURING INTERCOURSE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167814 ↗
• MalfunctionFeb 11, 2026Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE HAD NOTED ISSUES WITH INFLATION AND DEFLATION. IT TAKES THE PATIENT 20 PUMPS TO FULLY INFLATE THE DEVICE AND THE PATIENT CANNOT FULLY DEFLATE THE IPP DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316709 ↗
• InjuryDec 17, 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 (IPP) COMPLAINED OF PAIN, DISCOMFORT AND DIFFICULTY USING THE IMPLANT. UPON CLINICAL EXAMINATION, EROSION AT THE PUMP SITE WAS IDENTIFIED, WITH AN INFECTION LOCALIZED IN THE SCROTUM. THE PHYSICIAN BELIEVED THAT THE DEVICE CONTRIBUTED TO THE EROSION, AS THE PUMP WAS VISUALIZED BEGINNING TO ERODE THROUGH THE SKIN. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE ENTIRE DEVICE WAS REMOVED, AND NO REPLACEMENT DEVICE WAS IMPLANTED. THE INFECTION WAS TREATED WITH ANTIBIOTICS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Erosion; Pain; Unspecified Infection

  MAUDE report 23832217 ↗
• InjurySep 5, 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 (IPP) PRESENTED WITH PUMP EROSION THROUGH THE SCROTUM AND INFECTION. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM, WHERE THE DEVICE WAS REMOVED AND REPLACED WITH A TACTRA IMPLANT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22977472 ↗
• InjurySep 2, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING DISCOMFORT DUE TO PUMP POSITIONING. THE PATIENT STATED THAT THE PUMP IS PAINFUL, DIFFICULT TO REACH, AND CHALLENGING TO INFLATE AND DEFLATE. HE ALSO REPORTED THAT THE IPP PUMP IS PLACING PRESSURE ON THE ARTIFICIAL URINARY SPHINCTER (AUS) PUMP, CAUSING ADDITIONAL DISCOMFORT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22932669 ↗
• MalfunctionJul 11, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) IS EXPERIENCING AUTO-INFLATION DURING NORMAL DAILY ACTIVITIES. ACCORDING TO THE PHYSICIAN, THE PATIENT NOTICES UNINTENDED INFLATION OF THE DEVICE ON A DAILY BASIS. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480855 ↗
• InjuryJun 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 (IPP) PRESENTED WITH INFECTION AND EROSION, THE TUBING ERODED IN SCROTUM. PAIN AND SWELLING CONTINUED AFTER ANTIBIOTICS, THE IPP WAS EXPLANTED, FOLLOWED BY FULL MULCAHY IRRIGATION AND REPLACED WITH A TACTRA. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Erosion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22161160 ↗
• InjuryMar 20, 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) EXPERIENCED INFECTION, AND THE PUMP ERODED THROUGH THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE PUMP, AND THE SYSTEM WAS CAPPED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21652673 ↗