AMS 700™ CX TENACIO™ Pump 72404437Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00191506021382), received between Oct 22, 2024 and Jul 3, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (7 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 3, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE DEVICE NEVER REALLY WORKED PROPERLY. THE PATIENT FEELS LIKE THERE IS NO FLUID MOVING THROUGH THE SYSTEM AND IT BARELY INFLATES. FOUR-WEEK POST OPERATION, THE PHYSICIAN GIVES THE OK TO THE PATIENT TO USE THE DEVICE AND CYCLE IT; HOWEVER, THE PATIENT WAS IN PAIN AND WAS STILL QUITE BRUISED TO ATTEMPT TO CYCLE AT THAT TIME. THE PATIENT HAD AN APPOINTMENT WITH A DIFFERENT PHYSICIAN; HOWEVER, WAS NOT HELPFUL. THE DEVICE WAS FOUND TO BE PART OF THE TENACIO RECALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bruise/Contusion; Pain

  MAUDE report 25707126 ↗
• InjuryApr 21, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS HAVING DIFFICULTY INFLATING HIS DEVICE. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941253 ↗
• InjuryDec 19, 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 PAIN IN THE RIGHT SCROTUM AND EDEMA. ADDITIONALLY, THE PATIENT EXPERIENCED LOSS OF PENILE LENGTH DURING ERECTION. THE EVENTS OF PAIN AND EDEMA HAVE BEEN RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 23851984 ↗
• MalfunctionDec 15, 2025Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) REPORTED EXPERIENCING ISSUES WITH THE PUMP, INCLUDING DIFFICULTY INFLATING AND DEFLATING. THE PATIENT ALSO STATED THAT REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804544 ↗
• InjuryDec 3, 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) WAS NOT SATISFIED WITH THE TENACIO PUMP. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE PATIENT CORPORA WAS FOUND TO BE RUPTURED. THEREFORE, THE CYLINDERS AND PUMP WERE EXPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23711888 ↗
• InjuryNov 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE THE DEVICE. THE PATIENT DESCRIBED THE EXPERIENCE AS DISTRESSING AND FRUSTRATING. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 23463981 ↗
• InjuryOct 24, 2025Inflation Problem; Migration; Inflation Problem; Migration

  IT WAS REPORTED THAT ONE CYLINDER THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING DUE TO CROSSOVER. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23383539 ↗
• InjuryOct 24, 2025Inflation Problem; Material Puncture/Hole; Air/Gas in Device; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT AN UNRELATED ABDOMINAL SURGERY, DURING WHICH THE RESERVOIR WAS EMERGENTLY REMOVED. FOLLOWING THE REMOVAL, THE PATIENT WAS UNABLE TO INFLATE THE DEVICE. A HOLE AND THE PRESENCE OF AIR WITHIN THE DEVICE WERE NOTED AS A CONSEQUENCE OF THE RESERVOIR REMOVAL. AS A RESULT, ALL COMPONENTS OF THE PROSTHESIS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376348 ↗
• InjuryJul 16, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AUTO INFLATION AND INABILITY TO DEFLATE THE DEVICE. DURING EVALUATION, THE PHYSICIAN EXPLANTED AND TESTED THE SYSTEM, CONFIRMING THAT IT FUNCTIONED PROPERLY OUTSIDE THE BODY. HOWEVER, ONCE REIMPLANTED, THE RIGHT CYLINDER SLIGHTLY DEFLATED, WHICH THE PHYSICIAN ATTRIBUTED TO ANATOMICAL FACTORS. THE PUMP WAS SUBSEQUENTLY REPLACED, AND ADJUSTMENTS WERE MADE TO THE RIGHT CORPORA. THE DEVICE THEN FUNCTIONED AS EXPECTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522726 ↗
• InjuryMay 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 PRESENTED WITH AN INFECTION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD SWELLING AT THE INCISION SITE ALONG WITH AN INFLAMED SCROTUM. THE DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 21996274 ↗
• InjuryFeb 25, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED THE PUMP WAS SITTING HIGH AND SIDEWAYS IN HIS SCROTUM, CAUSING HIM ANXIETY AND CONCERNS THAT IT MAY AFFECT THE FUNCTIONALITY OF THE DEVICE. HE VISITED THE PHYSICIAN AND WAS ADVISED TO MANIPULATE THE PUMP TO REPOSITION IT. ADDITIONALLY, THE PATIENT REPORTED A SLIGHT INFECTION ON THE TIP OF HIS PENIS BEING TREATED WITH TOPICAL ANTIBIOTICS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21461825 ↗
• InjuryOct 22, 2024Migration; Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED CYLINDER CROSSOVER. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20510536 ↗