AMS 700™ CX TENACIO™ Pump 72404439Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00191506021405), received between Feb 26, 2025 and Jul 2, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN. THE PHYSICIAN STATED THAT THE PREVIOUS IMPLANT WAS OVERSIZED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH APPROPRIATE SIZE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25700111 ↗
• InjuryApr 22, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS TOO BIG FOR THE PATIENT AND THE ERECTION WAS NOT STRAIGHT AND NOT COMFORTABLE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN EXPLANTED THE IPP DEVICE, AND REMEASURED THE PATIENT AND REPLACED THE IPP DEVICE WITH A SIZE DOWN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 24958081 ↗
• InjuryFeb 19, 2026Mechanical Problem; Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A MECHANICAL ISSUE, AS THE USER WAS UNABLE TO ACTIVATE THE PUMP, THE PHYSICIAN SUSPECTS THAT THE MALFUNCTION MAY HAVE BEEN RELATED TO THE LOCATION OF THE RESERVOIR PLACEMENT. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390111 ↗
• InjuryNov 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM, PUMP BULB WAS REPEATEDLY COMPRESSED, WITH NO CYLINDER INFLATION. THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458511 ↗
• InjuryOct 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO FULLY INFLATE THE CYLINDERS WITH THE TENACIO PUMP. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TENACIO PUMP AND REPLACE WITH A MS PUMP. THE ORIGINAL CYLINDERS AND RESERVOIR REMAINED IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286033 ↗
• InjuryAug 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) COMPLAINED OF THE TENACIO PUMP BEING TOO STIFF. ADDITIONALLY, THE PATIENT EXPERIENCED INFLAMMATION. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation

  MAUDE report 22813337 ↗
• InjuryAug 8, 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 A SCROTAL ABSCESS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Abscess

  MAUDE report 22755376 ↗
• MalfunctionJul 28, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) ATTEMPTED TO INFLATE THE DEVICE AND NOTICED THE SOUND OF AIR OR FLUID MOVING WITHIN THE SYSTEM. SINCE THAT INCIDENT, HE HAS BEEN UNABLE TO OPERATE THE PUMP BULB. THE BULB APPEARED ROUNDED AND FIRM BUT DID NOT COMPRESS. THE PHYSICIAN ATTEMPTED TROUBLESHOOTING WITHOUT SUCCESS. THE DEVICE REMAINS IMPLANTED, AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631471 ↗
• InjuryJun 18, 2025Inflation Problem; Mechanical Problem; Defective Device; Inflation Problem; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS IPP EXPERIENCED DIFFICULTY INFLATING THE DEVICE, AS THE PUMP WAS TOO HARD TO COMPRESS. BOTH THE PATIENT AND THE PHYSICIAN NOTED THAT IT REQUIRED THE USE OF BOTH HANDS AND EXTENDED TIME TO INFLATE THE IPP. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285476 ↗
• MalfunctionJun 5, 2025Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE OF AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT SURGERY, THE DEVICE WAS PLACED AND DURING THE RESERVOIR TESTING, THE SYSTEM REFILL VALVE (SRV) WAS REPEATEDLY ACTIVATED AND THE DEVICE KEPT DEFLATING. AT THIS POINT, THE DEVICE WAS REPOSITIONED. THE PHYSICIAN DID BELIEVE THE DEVICE WAS STILL NOT REACHING FULL RIGIDITY BEFORE SRV WAS ACTIVATED; HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149705 ↗
• InjuryApr 1, 2025Deflation Problem; Fluid/Blood Leak; Inflation Problem; Use of Device Problem; Migration; Deflation Problem; Fluid/Blood Leak; Inflation Problem; Use of Device Problem; Migration

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DIFFICULTY INFLATING THE INFLATABLE PENILE PROSTHESIS (IPP) MORE THAN THREE QUARTERS ERECT, RESULTING IN INSUFFICIENT RIGIDITY FOR PENETRATION. ALSO, THE PATIENT NOTED DISCOMFORT AND DIFFICULTY WITH INFLATION AND DEFLATION WITH THEIR DEVICE AND STATED THAT THEY HAD NOT RECEIVED FORMAL PUMP TRAINING AND CONTACTED THEIR PHYSICIAN. THE PATIENT WAS COUNSELED ON EXPECTATIONS, THE DIFFERENCE BETWEEN NATURAL AND PROSTHETIC ERECTIONS, AND PROPER INFLATION TECHNIQUES. ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN SUSPECTED A FLUID LEAK WITHIN THE SYSTEM AND CONFIRMED THAT THE PUMP DID NOT SEAT WELL IN THE SCROTUM. A REPLACEMENT SURGERY WAS PERFORMED, DURING WHICH THE PUMP WAS REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748679 ↗
• InjuryFeb 26, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN EDEMA, INFLAMMATION AND HEMATOMA IN THE SCROTUM. UPON REVISION, IT WAS NOTED THAT THE PUMP WAS NOT PLACED IN THE ORIGINAL POCKET AT IMPLANT; THEREFORE, THE PUMP HAS BEEN REPOSITIONED AND THE HEMATOMA WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma; Inflammation; Swelling/ Edema

  MAUDE report 21471187 ↗