AMS 700™ CXR TENACIO™ Pump 72404463Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00191506021528), received between Jan 2, 2025 and Aug 20, 2026 — classified as 5 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-0143-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351070 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL PAIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN IDENTIFIED PURULENT MATERIAL (PUS) WITHIN THE SCROTUM, CONFIRMING THE PRESENCE OF AN INFECTION AT THE IMPLANT SITE. THE AFFECTED AREA WAS THOROUGHLY CLEANED AND THE IPP WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A TACTRA DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 25856053 ↗
• InjuryFeb 24, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED PUMP TUBING BUNCHING. DURING A SUBSEQUENT SURGICAL PROCEDURE, IT WAS DETERMINED THAT THE TUBING HAD BEEN INITIALLY TRIMMED TOO SHORT, CAUSING THE PUMP TO RIDE HIGH WITHIN THE PENOSCROTAL JUNCTION. THE PUMP WAS REPLACED WITH A NEW TENACIO PUMP TO PROVIDE ADEQUATE TUBING LENGTH AND ENSURE PROPER POSITIONING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434579 ↗
• MalfunctionOct 30, 2025Deflation Problem; Inflation Problem; Failure to Deflate; Deflation Problem; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY INFLATING AND DEFLATING THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425729 ↗
• InjuryMar 3, 2025Deflation Problem; Defective Device; Deflation Problem; Defective Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS TOO HARD TO PUMP AND SOMETIMES, THE DEVICE AUTO DEFLATES. IT WAS ALSO REPORTED PATIENT EXPERIENCED PAIN. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM WITHOUT PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 21510230 ↗
• MalfunctionFeb 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO ACTIVATE THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP), AND WHEN THEY REACHED WHAT THEY PERCEIVED AS 75% FULLNESS WITH FULL PUMPS, THE CYLINDERS WOULD NOT FILL ANY FURTHER. MULTIPLE ATTEMPTS WERE MADE TO PUMP AND INFLATE, BUT THE CYLINDERS ONLY REACHED FULL INFLATION WITH FLUTTER PUMPS FOR THE LAST 25%. NO SURGICAL INTERVENTION HAS BEEN INFORMED, AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322790 ↗
• InjuryJan 2, 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) EXPERIENCE A SCROTAL INFECTION. THE EXISTING IPP WAS EXPLANTED, A WASHOUT WAS PERFORMED AND THE DEVICE WAS REPLACED WITH A MALLEABLE IMPLANT. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 21064054 ↗