AMS 700 LGX™ TENACIO™ Pump 72404457Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00191506021474), received between Jan 16, 2025 and Sep 29, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Malposition of Device

  It was reported that this Inflatable Penile Prosthesis (IPP) was working but that since it was implanted the pump was riding high. During a clinic visit, the physician attempted to pull down the pump but reported that it seemed as good as it was going to get and that as long as it was working it was not a problem. More recently however, the pump seemed to be even higher to the point where the tubing was now rubbing on their pubic bone. When the patient is sitting, they have pain in their pelvic area, and they also reported that their penis is curved. The patient had Peyronies Disease and always had a slight curvature. However, they had the curvature fixed at the same time as their IPP implant surgery. The patient explained that the right cylinder was shorter than the left and was causing the penis to lean to the left. Per the patient it felt like the right cylinder was pushing outward through the side. The patient also saw their nurse practitioner (NP) who assessed it and was concerned about erosion of the cylinder over time because the skin on the side was very thin, but they were not an IPP specialist. The NP ordered a computed axial tomography (CAT) scan for (b)(6) 2026, to asse

  Patient problems: Deformity/ Disfigurement; Erosion; Pain

  MAUDE report 50937304 ↗
• InjurySep 22, 2026Inadequacy of Device Shape and/or Size; Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860448 ↗
• MalfunctionJun 26, 2026Mechanical Problem; Unintended Deflation

  IT WAS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT PROCEDURE, THE MEDICAL STAFF NOTED THAT THE VALVE PUMP WAS OPENING WHILE TRYING TO INFLATE THE DEVICE, RESULTING IN SPONTANEOUS DEFLATION; THEREFORE, A DIFFERENT PUMP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638499 ↗
• InjuryApr 28, 2026Migration; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN AND DISCOMFORT ASSOCIATED WITH THE PUMP AND REPORTED THAT THE PUMP HAD ADHERED TO THE SIDE OF THE SCROTUM. THE PATIENT ALSO REPORTED DIFFICULTY WITH DEFLATION, STATING THAT THE DEFLATION BUTTON WOULD BECOME STUCK AND REQUIRED REPEATED ATTEMPTS TO ACTIVATE. THE PATIENT INDICATED THAT THE DEVICE WAS ABLE TO INFLATE AS EXPECTED BUT THAT THE DEFLATION FUNCTION WAS INCONSISTENT. THE PATIENT HAS BEEN ADVISED TO FOLLOW UP WITH THE PHYSICIAN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 25017767 ↗
• InjuryApr 2, 2026Mechanical Problem

  IT WAS REPORTED THAT THE TENACIO PUMP OF THE INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY, AS IT COULD BARELY TRANSFER FLUID FROM THE PUMP TO THE CYLINDERS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TENACIO PUMP AND REPLACE IT WITH AN MS PUMP. THE NEW MS PUMP WAS CONNECTED TO THE REMAINING COMPONENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767735 ↗
• InjuryMar 25, 2026Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THE DEVICE DID NOT FUNCTION AS INTENDED, WITH PUMP FUNCTION DESCRIBED AS INCONSISTENT DURING INFLATION AND DEFLATION. THE PATIENT STATED THAT THE DEVICE INFLATED WITHOUT USER ACTIVATION AND DID NOT OPERATE AS EXPECTED WHEN DEFLATED. THE PATIENT REPORTED FOLLOW UP WITH THE TREATING UROLOGIST, WHO RECOMMENDED USE OF A VACUUM DEVICE AND STRETCHING EXERCISES; HOWEVER, THE PATIENT STATED THESE ACTIONS DID NOT RESOLVE THE REPORTED ISSUE AND THE ATTEMPTS TO OPERATE THE DEVICE WERE ASSOCIATED WITH PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24690883 ↗
• InjuryMar 24, 2026Inflation Problem; Failure to Deflate

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678204 ↗
• InjuryMar 2, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, IT NEVER GOT FULLY RIGID AND AFTER A LONG TIME OF PUMPING, IT WOULD BECOME REALLY HARD TO FULLY PUMP AT THE END AND THE CYLINDERS WERE NOT EVEN FULLY RIGID. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481835 ↗
• InjuryFeb 12, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A CONTRACTURE, SO THE DEVICE WAS NOT INFLATING PROPERLY. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Capsular Contracture

  MAUDE report 24325144 ↗
• InjuryJan 5, 2026Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES WHEN USING THE TENACIO PUMP. THE CYLINDERS WERE UNABLE TO FULLY INFLATE AND REMAINED SEMI-FLACCID. THE PATIENT ALSO REPORTED THAT THE PUMP WAS DIFFICULT TO OPERATE, RESULTING IN DISSATISFACTION. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE TENACIO PUMP WITH AN MS PUMP, WHICH IS EASIER FOR THE PATIENT TO USE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956052 ↗
• InjuryDec 3, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, IT IS VERY HARD AND DOES NOT ALLOW FOR FULL INFLATION, IT WAS ALSO REPORTED THAT THE PATIENT HAS PAIN FROM THE AMOUNT OF PRESSURE REQUIRED AND BLEEDING IN THE SCROTUM DUE TO THE PUMPING. THE IPP IS CURRENTLY IMPLANTED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 23710180 ↗
• InjuryAug 25, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE, AS HE WAS UNABLE TO PUMP IT TO FULL ERECTION AND DESCRIBED THE PUMP AS TOO HARD TO SQUEEZE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS CUT FROM THE CYLINDERS AND REPLACED WITH A NEW ONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890068 ↗
• MalfunctionAug 7, 2025Collapse; Inflation Problem; Mechanical Problem; Collapse; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) COULD ONLY BE PUMPED ONCE AND WOULD NOT INFLATE FURTHER. THE RELEASE VALVE FUNCTIONED, BUT NO ADDITIONAL FLUID ENTERED THE CYLINDERS. IMAGING IS BEING SCHEDULED TO ASSIST WITH TROUBLESHOOTING AND FURTHER EVALUATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740250 ↗
• InjuryJul 3, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO USE THIS INFLATABLE PENILE PROSTHESIS (IPP) AND EXPERIENCED DISCOMFORT. UPON EVALUATION, IT WAS OBSERVED THAT THE CYLINDERS HAD CROSSED OVER. AS A RESULT, THE DEVICE WAS EXPLANTED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Discomfort; Unspecified Tissue Injury

  MAUDE report 22401444 ↗
• InjuryJun 20, 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) EXPERIENCED PAIN IN THE SCROTUM AND INFECTION. THE IPP WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22299417 ↗
• InjuryMar 26, 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) EXPERIENCED INFECTION AT THE INCISION SITE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE IPP WAS REMOVED AND REPLACED WITH A TACTRA. THERE WERE NO DEVICE ISSUES AND NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 21700349 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HERNIATED. THE PUMP AND BALLOON WERE EXPLANTED AND REPLACED. THE PUMP WAS REPLACED WITH THE MOMENTARY SQUEEZE (MS) PUMP PER PATIENT PREFERENCE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170002 ↗