AMS 700 LGX™ TENACIO™ Pump 72404452Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00191506021436), received between Sep 16, 2024 and Sep 30, 2026 — classified as 1 death, 35 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (10 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Inflation Problem; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953788 ↗
• InjurySep 22, 2026Inflation Problem; Mechanical Problem; Nonstandard Device

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with difficulty inflating the device, unable to easily cycle the device, and described as being hard to squeeze with slow deflation. The patient reported needed to pump the device multiple times with minimal inflation achieved. During physician consultation, the physician confirmed that the device was not inflating as intended. The patient was guided on proper pumping technique, including anchoring and holding the pump by tubing and squeezing from the bottom of the bulb to obtain more effective compressions. A surgical procedure was performed during which the pump was explanted and replaced. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857745 ↗
• InjurySep 7, 2026Mechanical Problem; Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650905 ↗
• InjurySep 4, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size; Human-Device Interface Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) had difficulty cycling. A surgical procedure was performed during which the device was explanted and replaced. Upon explant the physician identified that the IPP was oversized. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602296 ↗
• InjuryJul 29, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) was unable to inflate the device. The pump remained compressed and flat due to fluid loss caused by a break in the pump connecting tubing. A surgical procedure was performed, during which the IPP was removed and replaced with a Tactra malleable device at the patient's request due to manual dexterity issues. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070023 ↗
• InjuryJul 20, 2026Inadequacy of Device Shape and/or Size; Malposition of Device

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced discomfort. The device was noted to be improperly positioned and oversized. As a result, the cylinders and pump were explanted and replaced with a smaller size, while the reservoir was retained. No further patient complications were reported.

  Patient problems: Discomfort

  MAUDE report 25876863 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL PAIN ASSOCIATED WITH MANIPULATION OF THE PUMP AND EXPRESSED DISSATISFACTION WITH THE PUMP COMPONENT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH NO DEVICE ISSUES WERE IDENTIFIED. THE IPP WAS SUBSEQUENTLY EXPLANTED, AND A FOLLOW UP SURGICAL PROCEDURE WAS SCHEDULED FOR PLACEMENT OF A MALLEABLE PROSTHESIS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25621276 ↗
• InjuryMay 12, 2026Migration

  IT WAS REPORTED THAT THE INFLATABLE PENIS PROSTHESIS (IPP) PRESENTED WITH EROSION AND THE CYLINDER WAS FELT IN THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED, AND THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS TO REPORT.

  Patient problems: Erosion

  MAUDE report 25150988 ↗
• InjuryApr 13, 2026Unintended Deflation

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A DEVICE THAT EASILY DEFLATED DURING USE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867698 ↗
• MalfunctionMar 6, 2026Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH PUMP INFLATION AND DEFLATION ISSUES. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2026 BUT HAD TO BE CANCELLED DUE TO LACK OF INSURANCE COVERAGE. THE PATIENT INFORMED THE CLINIC THAT HE INTENDED TO PURSUE LEGAL ACTION SINCE HE COULD NOT GET THE DEVICE FIXED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532362 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFECTION, SCROTAL PAIN, TENDERNESS, AND THE PUMP WAS ADHERENT TO THE SKIN AND SLIGHTLY SWOLLEN. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT AND THE IPP WAS EXPLANTED AND REPLACED WITH A MALLEABLE. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Adhesion(s); Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24422962 ↗
• InjuryJan 9, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that this Inflatable Penile Prosthesis (IPP) was no longer functioning properly and fluid loss from the system was reported. During surgical exploration, a break was identified in the tubing above the pump, resulting in fluid loss. The pump was replaced with a Tenacio pump, the reservoir was replaced and refilled, and the existing cylinders were retained. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022672 ↗
• InjuryDec 16, 2025Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A REVISION PROCEDURE TO ACTIVATE THE DEVICE. THE PHYSICIAN WAS UNABLE TO ACHIEVE FULL INFLATION, AS THE IMPLANT DID NOT INFLATE OR DEFLATE. THE PATIENT REPORTED THAT WHEN ATTEMPTING TO INFLATE THE DEVICE, THE PUMP FELT RIGID, HIS SCROTUM WAS VERY SORE, AND HE COULD NOT CONTINUE TRYING. THE DEVICE REMAINS IMPLANTED, AND A REPLACEMENT SURGERY IS PLANNED. THE PATIENT WAS ADVISED TO CONTACT HIS PHYSICIAN. NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 23820998 ↗
• InjuryNov 19, 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 SCROTAL EROSION AND INFECTION. THE PHYSICIAN NOTICED AN OPEN INFECTED WOUND IN THE SCROTUM. AS A RESULT, THE DEVICE WAS EXPLANTED AND A REPLACED WITH TACTRA. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 23598477 ↗
• InjuryOct 3, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PAIN DURING DEVICE DEFLATION, AND WHILE INFLATED, EXHIBITED A LEFT CORPORAL CURVATURE. IT WAS REPORTED THAT THE PATIENT WAS OVERSIZED DURING ORIGINAL PROCEDURE. THE IPP WAS EXPLANTED, A FULL WASHOUT WAS PERFORMED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 23211610 ↗
• InjurySep 25, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE PLACEMENT OF THE CYLINDERS, AS THE PREVIOUS IMPLANT HAD NOT BEEN FULLY DILATED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143486 ↗
• InjurySep 12, 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 SCROTAL INFECTION, PAIN, SWELLING AND REDNESS. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH TACTRA. NO FURTHER PATIENT COMPLICATIONS REPORTED.

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

  MAUDE report 23039558 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION, WITH PURULENT DISCHARGE OBSERVED AT THE INCISION SITE. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO DEVICE-RELATED ISSUES WERE IDENTIFIED, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 22910129 ↗
• InjuryJul 31, 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 IN THE SCROTUM AND PAIN. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22683586 ↗
• InjuryJul 23, 2025Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, THE PHYSICIAN REPORTED THAT THE PUMP FELT SQUISHY AND WAS INDICATIVE OF FLUID LOSS. IT WAS DISCOVERED THAT THE PUMP HAD AIR BUBBLES AND DARK FLUID. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577289 ↗
• InjuryJul 22, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO THE CLINIC WITH AN INABILITY TO INFLATE THE DEVICE. THE PHYSICIAN ATTEMPTED MANUAL INFLATION, BUT IT WAS UNSUCCESSFUL. A REVISION SURGERY WAS PERFORMED TO INVESTIGATE THE PUMP ISSUE. DURING SURGERY, IT WAS NOTICED FLUID LOSS FROM THE DEVICE. ALL COMPONENTS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565616 ↗
• InjuryJul 15, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Unintended Deflation; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Unintended Deflation

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT AUTO DEFLATES. A SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22514163 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN MANIPULATING THE INCISION SITE, WHICH RESULTED IN IT OPENING. THE IPP WAS EXPLANTED AND REPLACED WITH TACTRA. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22336550 ↗
• InjuryJun 23, 2025Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS ASSOCIATED WITH PATIENT DISSATISFACTION DUE TO DIFFICULTY INFLATING THE PUMP. THE ISSUE WAS PRIMARILY RELATED TO THE PATIENT'S FINGER GRIP. THE PUMP WORKED OUTSIDE OF THE BODY, BUT INSIDE THE BODY IT WOULD NOT PUMP UP PROPERLY. THE PHYSICIAN SUSPECTED POSSIBLE BACK PRESSURE OR KINKED TUBING. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308259 ↗
• MalfunctionJun 21, 2025Defective Device; Human-Device Interface Problem; Unintended Deflation; Defective Device; Human-Device Interface Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE PUMP BULB IS EXTREMELY FIRM, AND HE IS UNABLE TO COMPRESS IT. DURING AN ACTIVATION/PUMP TRAINING, THE NURSE PRACTITIONER WAS UNABLE TO INFLATE IT AND STATED THAT IT WAS VERY HARD. THE PATIENT WAS TOLD TO KEEP ATTEMPTING BUT HAS NO HAD SUCCESS. THE PATIENT STATED THAT HE DID INFLATE IT ONCE AND LEFT IT ERECT AND NOTICED THAT IT EVENTUALLY AUTO DEFLATED. THE PATIENT WAS SUGGESTED TO MAKE ANOTHER APPOINTMENT FOR DEVICE EVALUATION OR PUMP TRAINING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303483 ↗