AMS 700™ TENACIO™ Pump 72404420Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00191506021290), received between Sep 16, 2024 and Sep 28, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915501 ↗
• InjurySep 2, 2025Inflation Problem; Connection Problem; Inflation Problem; Connection Problem

  IT WAS REPORTED THAT THE PUMP TUBING OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DETACHED AT THE POINT WHERE THE TUBING CONNECTS WITH THE PUMP AT THE BASE, RESULTING IN INFLATION PROBLEMS. THE IPP WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947040 ↗
• MalfunctionAug 26, 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 DISCOMFORT AND PAIN ASSOCIATED WITH AND SCROTAL TENDERNESS AND REQUESTED TO SWITCH TO A MALLEABLE PROSTHESIS. A REVISION SURGERY HAS NOT YET BEEN SCHEDULED. THE DEVICE REMAINS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22896533 ↗
• MalfunctionAug 26, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISSATISFACTION ASSOCIATED WITH PAIN AND DISCOMFORT AND REQUESTED A REVISION TO SWITCH TO A MALLEABLE PROSTHESIS, AS HE PREFERRED A DEVICE WITHOUT A PUMP. REVISION SURGERY WAS SCHEDULED, BUT THE CASE WAS LATER CANCELLED FOR UNKNOWN REASONS. THE DEVICE REMAINS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 22896077 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ONCE THE PATIENT START INFLATING THE DEVICE IS DIFFICULT TO PUMP UP THE TENACIO IMPLANT. IT WAS REPORTED THAT THE PUMP WAS TOO DIFFICULT TO USE AND ROCK HARD. THE IPP IS CURRENTLY IMPLANTED. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146558 ↗
• InjuryJan 10, 2025Inflation Problem; Migration; Failure to Deflate; Inflation Problem; Migration; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT, SWELLING AND PAIN IN THE SCROTUM DUE TO PUMP PLACEMENT. IT WAS NOTED THAT THE RESERVOIR HAD HERNIATED. THE PUMP ALSO ROTATED AND IT WAS DIFFICULT TO FIND. IT WAS DIFFICULT TO INFLATE AND DEFLATE THE DEVICE. THERE IS A REVISION PROCEDURE BOOKED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 21125971 ↗
• MalfunctionSep 16, 2024Collapse; Inflation Problem; Collapse; Inflation Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING THE DEVICE. THE PUMP WOULD NOT PUMP AND STAY DEPRESSED. TROUBLESHOOTING MEASURES WERE PERFORMED BUT WERE UNSUCCESSFUL. THE IPP IS CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231052 ↗