AMS 700™ CX TENACIO™ Pump 72404434Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00191506021351), received between Jan 30, 2025 and Sep 7, 2026 — classified as 18 injuries, 2 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-0142-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2026Mechanical Problem; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651165 ↗
• InjuryAug 20, 2026Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360089 ↗
• InjuryJul 20, 2026Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY USING THE DEVICE AND WAS UNABLE TO OPERATE THE PUMP. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A POSSIBLE KINK IN THE TUBING WAS IDENTIFIED, CAUSING THE SYSTEM RELIEF FEATURE TO ACTIVATE. HOWEVER, THE PUMP FUNCTIONED NORMALLY IN THE OPERATING ROOM. THE MS PUMP WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876872 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS HAVING TROUBLE LOCATING AND USING THE PUMP DUE TO CAPSULE AND HEMATOMA. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 25830654 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE DEVICE WAS EXPLANTED. A FULL WASHOUT WAS COMPLETED DURING THE PROCEDURE, AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 25673584 ↗
• InjuryMay 8, 2026Inflation Problem

  IT WAS REPORTED THAT A PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS DIFFICULT TO INFLATE. A SURGICAL PROCEDURE WAS PERFORMED AND THE PUMP WAS REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124337 ↗
• InjuryMay 6, 2026Unintended Deflation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED SPONTANEOUS DEFLATION. UPON ASSESSMENT, THE PHYSICIAN FOUND THE CYLINDERS WOULD INFLATE FOR A SHORT PERIOD BUT DEFLATING WITHOUT MANIPULATING THE DEFLATION BUTTON. IT WAS DETERMINED FLUID REMAINED IN THE RESERVOIR, SO THE PHYSICIAN ELECTED TO REPLACE ONLY THE PUMP COMPONENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104832 ↗
• InjuryMar 17, 2026Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT HE FEELS THAT THE TENACIO PUMP REQUIRED AN EXCESSIVE FORCE TO INFLATE THE CYLINDERS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE TENACIO PUMP AND REPLACE WITH A NEW MS PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617751 ↗
• InjuryDec 11, 2025Loss of or Failure to Bond; Inflation Problem; Loss of or Failure to Bond; Inflation Problem

  It was reported that the patient complications using their Inflatable Penile Prosthesis (IPP) implant device and the device was attempted to be used by the patient following activation, both the patient and physician identified that the pump was not functioning properly for sufficient inflation and use. Scar tissue made it difficult to pump. No air was observed, there were no holes observed in the system, and the pump did not stay flat. The most likely/suspected cause of the customer reported issue was an overly sensitive pressure relief mechanism, and the scar tissue described most likely developed after the previous implantation. Additionally, there was a potential slight right cylinder buckling in the distal corpora. The physician removed and replaced the cylinder and pump through replacement surgery with a new cylinder/pump system connected to the existing reservoir, and there were no further signs or symptoms reported.

  Patient problems: Scar Tissue

  MAUDE report 23775410 ↗
• InjuryDec 2, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING DIFFICULTY PUMPING THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693969 ↗
• InjuryNov 12, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS HAVING DIFFICULTY WITH THE PUMP, IT WAS FIRMER THAN NORMAL. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVED AND REPLACE THE PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533228 ↗
• InjuryOct 1, 2025Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INFLATE OR DEFLATE THE TENACIO PUMP OF HIS INFLATABLE PENILE PROSTHESIS (IPP). THE PATIENT EXPERIENCED ANXIETY OVER HIS IMPLANT NOT FUNCTIONING PROPERLY, WHICH WAS ATTRIBUTED TO A BUCKLED CYLINDER. ADDITIONALLY, THE PATIENT HAD DEXTERITY ISSUES AND EXPRESSED A PREFERENCE FOR A MS PUMP. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN WAS ABLE TO OPERATE THE DEVICE WITHOUT DIFFICULTY. NEVERTHELESS, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Anxiety

  MAUDE report 23195848 ↗
• InjuryOct 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) HAD REPORTED NEEDING 70 TO 100 PUMPS TO ACHIEVE AN ERECTION AND HAD PREVIOUSLY EXPERIENCED DIFFICULTY INFLATING THE DEVICE DURING EVALUATIONS BY A HEALTH CARE PROFESSIONAL (HCP). AFTER CONFIRMING THE PROPER TECHNIQUE, THE DEVICE STILL REQUIRED 20 TO 30 COMPRESSIONS TO TRANSFER FLUID AND ACHIEVE AN ERECTION. A REPLACEMENT SURGERY WAS PERFORMED IN (B)(6) 2025 IN WHICH PHYSICIAN CONFIRMED THE TENACIO PUMP ISSUES, DESCRIBING DIFFICULTY IN PUMPING AND IMPLANTED A MS PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23191663 ↗
• InjurySep 25, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE, AS HE HAD TROUBLE INFLATING IT TO FULL PRESSURE AND WAS UNABLE TO ACHIEVE SUFFICIENT RIGIDITY FOR PENETRATION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144165 ↗
• InjurySep 25, 2025Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE, AS HE REPORTED DIFFICULTY ACHIEVING SUFFICIENT RIGIDITY FOR PENETRATION. THE DEVICE WAS NOTED TO LOSE PRESSURE DURING INTERCOURSE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143492 ↗
• InjuryJun 13, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED CYLINDERS CROSSOVER. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS AND PUMP. THE ORIGINAL RESERVOIR KEPT IMPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22203239 ↗
• MalfunctionMay 21, 2025Mechanical Problem; Failure to Deflate; Mechanical Problem; Failure to Deflate

  IT WAS REPORTED THAT IN (B)(6) 2024, A SURGICAL PROCEDURE WAS PERFORMED TO IMPLANT A TENACIO SYSTEM (INFLATABLE PENILE PROSTHESIS). THE PATIENT THEN CONFIRMED THE PUMP SEEMS STIFFER AND MORE DIFFICULT TO SQUEEZE, LEADING TO MORE PARTIAL SQUEEZES THUS NEGATING THE GREATER POTENTIAL EFFICIENCY AND IT IS MORE PRONE TO SLIP AROUND IN THE SCROTUM WHILE SQUEEZING. THE OVERSIZED DEFLATION BUTTON IS HARDER TO SUCCESSFULLY DEPRESS AND THE POPPING SOUND TO CONFIRM DEFLATION WAS USUALLY NOT AUDIBLE AND NOT RELIABLE. THE DEFLATION STOPPED MULTIPLE TIMES DURING THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061713 ↗
• MalfunctionMay 7, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ONCE THE INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED, PHYSICIAN TRIED TO INFLATE IT. HOWEVER, AT CERTAIN POINT THE FLUID FROM EACH PUMP JUST CAME BACK TO THE PUMP BULB, AND THE DEVICE NEVER BECAME FULLY RIGID. PUMP RESET WAS TRIED, BUT STILL THE SAME ISSUE. NO REVISION SURGERY HAS BEEN INFORMED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976445 ↗
• InjuryApr 2, 2025Inflation Problem; Malposition of Device; Migration; Failure to Deflate; Inflation Problem; Malposition of Device; Migration; Failure to Deflate

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HERNIATED, AND THE PUMP HEALED TOO HIGH IN THE SCROTUM MAKING IT DIFFICULT TO INFLATE AND DEFLATE. THE RESERVOIR AND PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757082 ↗
• InjuryJan 30, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SWELLING IN THE SCROTUM AFTER SEXUAL INTERCOURSE. DURING REVISION, IT WAS FOUND THAT BOTH CYLINDERS HAD RUPTURED THE CORPORAL BODIES AND MIGRATED TO THE SCROTUM; THEREFORE, THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Swelling/ Edema

  MAUDE report 21274023 ↗