AMS 700 LGX™ TENACIO™ Pump 72404458Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00191506021481), received between Apr 23, 2025 and Jul 27, 2026 — classified as 5 injuries, 1 malfunction.

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 27, 2026Inflation Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with auto inflation and dissatisfaction with the pump location. A revision surgery was performed, during which the physician explanted and replaced the device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038238 ↗
• InjuryDec 16, 2025Degraded; Migration; Degraded; Migration

  IT WAS REPORTED THAT DURING INSPECTION OF AN INFLATABLE PENILE PROSTHESIS (IPP), THE RIGHT CYLINDER WAS NOT PROPERLY SEATED AND PRESENTED A SLIGHT BULGE. INTRAOPERATIVELY, BOTH CYLINDERS WERE FOUND TO BE MALPOSITIONED, POSSIBLY DUE TO PROXIMAL CROSSOVER. THE PATIENT EXPERIENCED DISCOMFORT. AS A RESULT, THE DEVICE WAS EXPLANTED, AND THE PHYSICIAN RECOMMENDED ALLOWING THE PATIENT TO HEAL BEFORE RETURNING IN A FEW MONTHS FOR RE-IMPLANTATION. NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Discomfort; Unspecified Tissue Injury

  MAUDE report 23822349 ↗
• InjuryDec 15, 2025Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) presented to clinic with complaint of device not easily inflating and deflating. As a result, the pump was explanted and replaced. No patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809770 ↗
• MalfunctionAug 8, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT STAY INFLATED DURING USE. THE ISSUE WAS REPORTED DURING A ROUTINE FOLLOW-UP APPOINTMENT. THE PHYSICIAN CYCLED THE DEVICE IN-OFFICE AND DISCUSSED THE PRESSURE RELEASE MECHANISM. REPLACEMENT OF THE PUMP IS BEING CONSIDERED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749212 ↗
• InjuryApr 24, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT AND PAIN IN THE SCROTUM. THE PUMP RETRACTED VERY HIGH AND DEEP INTO THE SCROTUM, MAKING THE DEFLATION BUTTON HARDER TO FIND. THIS HAS MADE IT DIFFICULT TO TRAIN THE PATIENT ON HOW TO INFLATE AND DEFLATE THE DEVICE. SURGERY TO REPOSITION THE PUMP MAY BE REQUIRED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 21899651 ↗
• InjuryApr 23, 2025Inflation Problem; Patient-Device Incompatibility; Migration; Failure to Deflate; Inflation Problem; Patient-Device Incompatibility; Migration; Failure to Deflate

  A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS DEVICE REPORTED DISCOMFORT AND PAIN IN THE SCROTUM AND HAD DIFFICULTIES DURING THE CYCLING ACTIVATION APPOINTMENT, BEING UNABLE TO EASILY INFLATE OR DEFLATE THE DEVICE. ATTEMPTS TO MANIPULATE THE PUMP WERE UNSUCCESSFUL, AND THE PATIENT WAS ADVISED TO PRACTICE AT HOME. THE PHYSICIAN OBSERVED THAT THE PUMP RETRACTED AND MIGRATED HIGH AND DEEP IN THE SCROTUM, MAKING THE DEFLATION BUTTON HARD TO FIND AND LACKING TACTILE FEEDBACK, COMPLICATING TRAINING. NO MEDICAL OR SURGICAL INTERVENTIONS HAVE BEEN MADE YET, BUT THE PHYSICIAN BELIEVES A PUMP REPOSITIONING MAY BE NECESSARY AND SUSPECTS THE PUMP CAUSED THE PAIN AND DISCOMFORT. IT WAS ALSO CONFIRMED BY THE PHYSICIAN THAT THERE WAS NO EXTERNAL PRESSURE OR TRAUMA TO THE PELVIC REGION OR ABDOMEN PRIOR TO THE APPOINTMENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Discomfort; Pain

  MAUDE report 21893163 ↗