AMS 700™ CX TENACIO™ Pump 72404432Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00191506021337), received between Dec 13, 2024 and Sep 25, 2026 — classified as 61 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (27 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-0142-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Deflation Problem; Inflation Problem; Unintended Deflation

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP), experienced difficulty operating the device. The patient reported that the deflation button would stick and would not release when pressed. The patient also reported episodes of auto inflation during sleep and stated that the device auto deflated during attempted use. Additionally, the patient indicated that repeated pumping did not appear to fully inflate the cylinders. Upon inspection, reservoir appeared to be scarred in vivo. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: Adhesion(s)

  MAUDE report 50900285 ↗
• InjurySep 23, 2026Inflation Problem; Migration

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with a device that would not provide sufficient rigidity on one side and would not fully inflate on both sides. A revision surgery was performed, during which the physician confirmed that the right cylinder had migrated proximally within the corpora. The device was explanted and replaced. There were no further patient complications.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50869613 ↗
• InjurySep 23, 2026Collapse; Inflation Problem

  It was reported that the patient with an Inflatable Penile Prosthesis (IPP) experienced device auto-inflation and difficulty inflating the device since the initial implant procedure. The auto-inflation was reportedly observed during office evaluations, and the pump was described as feeling gummy during use. A revision procedure was performed during which the Tenacio pump was explanted and replaced with an MS pump. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867420 ↗
• InjurySep 1, 2026Degraded; Inflation Problem; Infusion or Flow Problem; Migration

  It was reported that the Inflatable Penis Prosthesis (IPP) started to bulge at the left cylinder corporal site about four months after implantation. Patient then had unrelated abdominal procedures in which the reservoir may have been displaced. As a result, the device was removed and replaced with a Tactra per Dr. request. No further patient complications were reported.

  Patient problems: Discomfort

  MAUDE report 50553497 ↗
• InjuryAug 17, 2026Nonstandard Device

  It was reported that the cylinders of an Inflatable Penile Prosthesis (IPP) were returned without any performance allegation. Upon analysis, a bulge was identified in the first cylinder.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280354 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with pain. A revision surgery was performed, during which the physician confirmed infection and obtained a culture swab during the procedure. The device was explanted and replaced. There were no further patient complications.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50099502 ↗
• InjuryJul 1, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Unintended Deflation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PUMP WOULD NOT INFLATE OR DEFLATE. THE PUMP IS EITHER ROCK HARD OR ONCE STARTED IT IS VERY DIFFICULT TO INFLATE. THERE WAS ALSO AUTO DEFLATION ISSUES. THE PHYSICIAN ATTEMPTED TROUBLESHOOTING WITH NO SUCCESS. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN NOTED BLOOD IN THE DEVICE AND THE RESERVOIR HAD A HOLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686135 ↗
• InjuryJun 11, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT ABLE TO FULLY INFLATE. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480021 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION SECONDARY TO AN OPEN SCROTAL INCISION. THE PATIENT PRESENTED WITH A VERY SMALL WOUND IN THE PENOSCROTAL AREA THAT WAS DRAINING BROWNISH FLUID, ALONG WITH PAIN ON THE LEFT SIDE OF THE SCROTUM. AS A RESULT, THE CYLINDERS AND PUMP WERE REMOVED, AND THE TUBING WAS PLUGGED. A TACTRA DEVICE WAS IMPLANTED IN THE CORPORA. THE INFECTION WAS TREATED WITH ANTIBIOTICS AND WASHOUT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fluid Discharge; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 25437873 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFECTION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA FOR NOW. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25294247 ↗
• InjuryMay 22, 2026Inflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS NOT SATISFIED WITH THE RIGIDITY OF AN INFLATABLE PENILE PROSTHESIS (IPP) EQUIPPED WITH A TENACIO PUMP, AS IT DID NOT ACHIEVE FULL INFLATION. AS A RESULT, THE TENACIO PUMP WAS REMOVED AND REPLACED WITH A NEW MS PUMP. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260662 ↗
• InjuryMay 18, 2026Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT ASSOCIATED WITH THE PUMP AND EXPRESSED DISSATISFACTION WITH THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 25211217 ↗
• InjuryMay 13, 2026Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE DEVICE WAS ALWAYS DIFFICULT TO INFLATE. SUBSEQUENTLY, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. THE EXPLANTED PUMP WAS TESTED AND WAS NOTED TO BE DIFFICULT TO INFLATE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166453 ↗
• InjuryApr 29, 2026Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT A PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) TUBING LENGTH WAS TOO SHORT, THE PUMP WAS HIGHER THAN EXPECTED AND THE IMPLANT WAS UNDERSIZED. THE DEVICE WAS EXPLANTED AND REPLACED WITH A MORE SUITABLE SIZE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038125 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE HAD ERODED THE BASS TISSUE ACCUMULATED OVER MULTIPLE PROCEDURES. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN EXPLANTED THE RIGHT CYLINDER. THE PHYSICIAN EXPLANTED THE PUMP DUE TO WHAT THE PATIENT DESCRIBED AS A POKING SENSATION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Erosion

  MAUDE report 25034516 ↗
• InjuryApr 15, 2026Malposition of Device

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED FOR ROUTINE FOLLOW-UP AT WHICH TIME DISTAL EROSION OF THE RIGHT CYLINDER WAS OBSERVED. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED WITH NEW COMPONENTS WHILE THE RESERVOIR WAS DRAINED AND REFILLED. THE DEVICE WAS TESTED AND FOUND TO FUNCTION AS EXPECTED. IT WAS NOTED THE PATIENT HAD POOR TISSUE QUALITY WHICH MAY HAVE CONTRIBUTED TO THE EROSION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 24888488 ↗
• InjuryApr 9, 2026Inflation Problem; Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DISTAL CROSSOVER, WITH THE RIGHT SIDE NOT EXTENDING FULLY TO THE MID GLANS. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24834950 ↗
• InjuryApr 7, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD DIFFICULTIES WITH THE ACTIVATION OF HIS DEVICE. AS A RESULT, THE TENACIO PUMP WAS EXPLANTED AND REPLACED WITH A MS PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801735 ↗
• MalfunctionMar 26, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AUTO INFLATION. SURGICAL INTERVENTION IS NOT NECESSARY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700193 ↗
• InjuryMar 25, 2026Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DIFFICULTY USING THE TENACIO PUMP AND REPORTED THAT THE IMPLANT WAS NOT RIGID ENOUGH. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE PUMP CYCLED WELL IN THE OPERATING ROOM PRIOR TO INCISION. THE PHYSICIAN EXPLANTED AND REPLACED THE CYLINDERS AND THE TENACIO PUMP WITH SAME SIZE CYLINDERS AND AN MS PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690041 ↗
• InjuryMar 19, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCE DIFFICULTY INFLATING TO FULL PRESSURE. IN THE OPERATING ROOM, THE DEVICE CYCLED APPROPRIATELY; HOWEVER, THE PATIENT WAS DISSATISFIED WITH IT. AS A RESULT, THE TENACIO PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED WITH AN MS PUMP AND CYLINDERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641775 ↗
• InjuryMar 4, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, AS IT WOULD AUTO INFLATE. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505642 ↗
• InjuryMar 2, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY CYCLING THE IMPLANT, AND FLUID WAS OBSERVED LEAKING. DURING SURGICAL EVALUATION, THE RESERVOIR WAS FOUND TO BE PUNCTURED. THE IPP WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482650 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFECTION, PAIN AND SWELLING. THE IPP WAS EXPLANTED, WASHED OUT AND REPLACED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24277636 ↗
• InjuryJan 29, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH PAIN, IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO INFLATE. THE IPP WAS EXPLANTED AND REPLACED WITH MALLEABLE. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Pain

  MAUDE report 24215482 ↗