AMS 700 LGX™ TENACIO™ Pump 72404453Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191506021443), received between Dec 11, 2024 and Jul 10, 2026 — classified as 6 injuries.

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-0144-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced pump erosion through scrotal incision. As a result, the device was explanted and replaced with malleable. No further patient complications were reported.

  Patient problems: Erosion; Wound Dehiscence

  MAUDE report 25786451 ↗
• InjuryJul 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION OF THE PUMP AT THE SCROTUM. THE EROSION WAS SUSPECTED TO HAVE BEEN CAUSED BY PRESSURE; HOWEVER, IT WAS NOT CONFIRMED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP WITH A TACTRA DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 25704815 ↗
• InjuryJun 24, 2025Inflation Problem; Mechanical Problem; Migration; Inflation Problem; Mechanical Problem; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS IPP EXPERIENCED SIGNIFICANT POST OPERATIVE DISSATISFACTION, REFERRING TO IT AS THE MOST NEGATIVE SURGICAL EXPERIENCE TO DATE. THE PATIENT REPORTED BEING UNABLE TO FULLY INFLATE THE CYLINDERS, EXPERIENCING ONGOING SORENESS AND DISCOMFORT AT THE INCISION SITE, AND ACHIEVING ONLY PARTIAL INFLATION. THE PUMP WAS DESCRIBED AS EXTREMELY STIFF, RAISING CONCERNS ABOUT A POSSIBLE STICKY VALVE. ADDITIONALLY, THE PHYSICIAN NOTED DURING A PRIOR VISIT THAT THE PUMP APPEARED TO BE POSITIONED HIGHER AND TO THE LEFT WITHIN THE SCROTUM. THE PATIENT MENTIONED THAT ATTEMPTS TO INFLATE THE DEVICE IN WARM WATER PROVIDED SOME RELIEF. A FOLLOW UP APPOINTMENT IS SCHEDULED FOR FURTHER PHYSICIAN EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 22324481 ↗
• InjuryFeb 11, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE PUMP RIDING HIGH IN THE SCROTUM, MAKING THE COMPONENT DIFFICULT TO OPERATE; THEREFORE, A REVISION SURGERY WAS PERFORMED TO REMOVE THE TENACIO PUMP AND REPLACE IT WITH A MS PUMP. THE PHYSICIAN STATED THE MIGRATION MAY BE DUE TO THE NEW LOCATION OF THE RESERVOIR TUBING CONNECTING TO THE TENACIO PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355867 ↗
• InjuryJan 30, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFLATION ISSUES. IT WAS NOTED THERE WAS FLUID LOSS DUE TO THE LEFT CYLINDER WAS BROKEN AND FRAYED. THE IPP WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275666 ↗
• InjuryDec 11, 2024Deflation Problem; Inflation Problem; Mechanical Problem; Malposition of Device; Migration; Deflation Problem; Inflation Problem; Mechanical Problem; Malposition of Device; Migration

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT HE HAS BEEN RECENTLY IMPLANTED AND TRAINED BUT IS UNABLE TO INFLATE OR DEFLATE THE DEVICE DUE TO THE HIGH POSITIONING OF THE PUMP. HE STATED THAT IT IS ALSO VERY UNCOMFORTABLE AS IT PRESSES AGAIN THE BASE OF HIS SHAFT AND IS VISIBLE THROUGH CLOTHING. HE STATED HE DID DISCUSS THIS WITH HIS DOCTOR, WHO STATED IT COULD NOT BE MANIPULATED OUTSIDE SURGERY IF AT ALL AND WAS OFFERED TACTRA AS POTENTIAL OPTION. PATIENT STATED THAT WHEN HE DOES PRESS THE BULB, HE DOES NOT TRANSFER ANY FLUID TO THE CYLINDERS. THE PATIENT SPECIALIST DISCUSSED WITH THE PATIENT PROPER INFLATION TECHNIQUES AND POSITION AND ATTEMPTING IN A WARM SHOWER. THE PATIENT SPECIALIST SUGGESTED HIM TO BE SEEN BY HIS DOCTOR AGAIN FOR FURTHER EVALUATION AND TO DISCUSS NEXT STEPS.

  Patient problems: Discomfort

  MAUDE report 20904118 ↗