AMS 700 LGX™ TENACIO™ Pump 72404456Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00191506021467), received between Jan 10, 2025 and Sep 25, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (5 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-0144-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903844 ↗
• InjuryJul 1, 2026Inflation Problem; Malposition of Device; Migration

  IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTED INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY AND DISSATISFACTION IN MANIPULATING THE TENACIO PUMP. THE PATIENT INDICATED THAT, DUE TO ITS POSITION, HE WAS UNABLE TO ACHIEVE MORE THAN 50% INFLATION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE TENACIO PUMP WAS EXPLANTED AND REPLACED WITH AN MS PUMP. ADDITIONALLY, IT WAS CONFIRMED THAT THE DIFFICULTY IN MANIPULATION WAS ASSOCIATED WITH PUMP MIGRATION AND MALPOSITION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680078 ↗
• MalfunctionMay 7, 2026Unintended Deflation

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) ATTEMPTED TO PUMP THE DEVICE, BUT THE CYLINDERS QUICKLY DEFLATED SEVERAL TIMES. THE DEVICE WAS CHECKED TO CONFIRM IF THERE WERE KINKED TUBES, BUT KINKS WERE NOT REPORTED. AN EXPLANT SURGERY HAS BEEN SCHEDULED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117992 ↗
• InjuryMar 2, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PROPERLY SIZED, TIPS SITTING TOO LOW IN CORPORA. THE IPP WAS EXPLANTED AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481589 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH SWELLING AND A POSSIBLE INFECTION AT THE INCISION SITE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND REPLACED WITH A MALLEABLE DEVICE. THE INFECTION WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 23959976 ↗
• InjuryJan 2, 2026Inflation Problem; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS HARD TO SQUEEZE AND HAD FLIPPED UPSIDE DOWN IN THE SCROTUM, CAUSING DISCOMFORT. THE PATIENT STATED HE WAS UNABLE TO FULLY INFLATE THE CYLINDERS. THE PHYSICIAN CONFIRMED THAT THE PUMP WAS DIFFICULT TO OPERATE, HAD FLIPPED UPSIDE DOWN IN THE SCROTUM, AND SUSPECTED THAT THE TUBING WAS TOO LONG. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Discomfort

  MAUDE report 23946092 ↗
• InjuryDec 31, 2025Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PUMP, TENACIO MODEL, EXHIBITED ISSUES WITH INFLATION AND MAINTAINING RIGIDITY. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE TENACIO PUMP WITH AN MS PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935716 ↗
• InjuryAug 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THE INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED LIMPNESS. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750476 ↗
• InjuryMay 16, 2025Deflation Problem; Unintended Deflation; Deflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DEFLATION DURING INTERCOURSE WITH TENACIO PUMP. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035869 ↗
• InjuryApr 24, 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 FLUID IN THE SCROTUM. AS PER REVISION SURGERY PHYSICIAN ATTRIBUTED THAT THE HEMATOMA WITHIN THE CORPORAL BODIES AND THE FLUID IN THE SCROTUM TO THE PATIENT MEDICATION. THE DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 21901323 ↗
• InjuryJan 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS AUTO INFLATING. THE IPP WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123713 ↗