AMS 700 LGX™ TENACIO™ Pump 72404451Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00191506021429), received between Feb 24, 2025 and Sep 10, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (5 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 10, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722320 ↗
• InjurySep 3, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576881 ↗
• InjuryAug 18, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) felt a pop. The device exhibited fluid loss. A surgical procedure was performed, during which a hole in the tubing extending from the pump to one of the cylinders was identified. As a result, the device was removed. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306571 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced pain. A surgical procedure was performed during which the IPP was removed and replaced with a malleable device. No additional patient complications were reported.

  Patient problems: Pain

  MAUDE report 50152101 ↗
• InjuryJun 29, 2026Nonstandard Device; Unintended Deflation

  IT WAS REPORTED THAT FOLLOWING INITIAL ACTIVATION OF THIS INFLATABLE PENILE PROSTHESIS (IPP); THE DEVICE EXHIBITED SPONTANEOUS DEFLATION DURING INTERCOURSE. THE PATIENT CONSULTED THEIR PHYSICIAN AND WAS GUIDED TO WAIT FOR AN ADDITIONAL PERIOD BEFORE ATTEMPTING USE OF THE DEVICE. APPROXIMATELY 3-4 MONTHS AFTER IMPLANT, THE PATIENT WAS GIVEN CLEARANCE TO USE THE DEVICE ONCE MORE AND THE PATIENT EXPERIENCED SPONTANEOUS DEFLATION AGAIN. A SURGICAL PROCEDURE WAS THEN PERFORMED DURING WHICH THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661316 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION OF THE CYLINDER IN THE DISTAL URETHRA WHICH CAUSED URINARY RETENTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Urinary Retention

  MAUDE report 25437415 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN IN THE SCROTUM AND PERINEUM. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED DISTAL EROSION OF A CYLINDER. THE DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Erosion; Pain

  MAUDE report 25009943 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL INFECTION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA. THERE WERE NO DEVICE ISSUES AND NOT FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 24801721 ↗
• InjuryFeb 27, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS UNDERSIZED. THE IPP WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472334 ↗
• InjuryJan 6, 2026Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) TENACIO PUMP, EXHIBITED INFLATION AND DEFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23983537 ↗
• InjuryDec 30, 2025Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM DUE TO A FLUID LOSS OBSERVED AT THE LOCATION OF BREAK IN THE CYLINDER PUMP INSERTION SITE JUNCTION. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921147 ↗
• InjuryNov 18, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL PAIN, SWELLING, REDNESS, AND PUMP MIGRATION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED AN INFECTION IN THE SCROTUM STARTED ONE WEEK PRIOR THE PROCEDURE. THE ENTIRE DEVICE WAS EXPLANTED AND DISCARDED, THE AREA WAS FULLY CLEANED AND IRRIGATED HEAVILY, AND ONLY NEW CYLINDERS WERE IMPLANTED AS A PLACEHOLDER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 23584092 ↗
• InjuryOct 21, 2025Inflation Problem; Mechanical Problem; Failure to Deflate; Inflation Problem; Mechanical Problem; Failure to Deflate

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED DIFFICULTY INFLATING AND DEFLATING DUE TO A MECHANICAL PROBLEM WITH THE PUMP. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349381 ↗
• MalfunctionSep 2, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED BY THE PATIENT THAT HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS ACTIVATED LAST WEEK AND HE RECEIVED TRAINING ON HOW TO PUMP THE DEVICE. HE STATED THE TRAINING WAS VERY QUICK AND DID NOT PROVIDE ADEQUATE INFORMATION. WHEN PRESSING THE PUMP BULB IT FEELS VERY HARD WHEN TRYING TO INFLATE THE DEVICE. ADDITIONALLY, THE BASE OF HIS PENIS HURTS. HE ALSO STATED THAT WHEN THE DEVICE IS INFLATED, THE ERECTION DOES NOT STICK STRAIGHT OUT AND THE HEAD OF HIS PENIS IS FLOPPY, MAKING IT DIFFICULT FOR PENETRATION. WHEN THE DEVICE IS INFLATED, IT IS CAUSING SORENESS AND TENDERNESS, AND THE PATIENT FEELS SWELLING IN THE SCROTUM. HE IS TAKING PAIN MEDICATIONS AS A RESULT. THE PATIENT IS GOING TO CONSULT WITH ANOTHER PHYSICIAN TO GET EVALUATED.

  Patient problems: Deformity/ Disfigurement; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 22948031 ↗
• InjuryJun 12, 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) EXPERIENCED DRAINAGE FROM A TRACT AND FLUID BUILDUP IN THE SCROTUM. A FULL WASHOUT WAS PERFORMED, AND THE IPP WAS REMOVED AND REPLACED. THE FLUID BUILDUP WAS NOT RELATED TO THE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 22198675 ↗
• InjuryJun 9, 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) PRESENTED WITH INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS, THE IPP WAS EXPLANTED AND REPLACED WITH TACTRA. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22169215 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO AN INFECTION, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE INFLATABLE PENILE PROSTHESIS (IPP) SYSTEM AND PLACE WITH A TACTRA AS A SPACE SAVER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Unspecified Infection

  MAUDE report 21454129 ↗