AMS 700™ CX TENACIO™ Pump 72404438Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00191506021399), received between Jul 17, 2024 and Sep 21, 2026 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (17 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) had a scrotal trauma at the pump location and now reports pain, with bacterial growth present around the testicular area. A surgical procedure was performed to remove the IPP. No device issues were reported. No additional patient complications were reported.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 50847255 ↗
• InjuryJul 2, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY INFLATING THE DEVICE AND STATED THAT EXCESSIVE AND FORCEFUL PUMPING WAS REQUIRED, WHICH WAS CHALLENGING DUE TO HIS HYDROCELE. THE DEVICE NEVER REALLY INFLATED PROPERLY. TROUBLESHOOTING WAS PERFORMED, INCLUDING SEVERAL APPOINTMENTS AND TRAINING SESSIONS; HOWEVER, IT WAS UNSUCCESSFUL IN RESOLVING THE ISSUE. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 25698421 ↗
• InjuryMay 18, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY PUMPING THE DEVICE AND REPORTED THAT IT WAS NOT INFLATING FULLY. PATIENT DISSATISFACTION WAS REPORTED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197328 ↗
• InjuryApr 10, 2026Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS HAVING DIFFICULTY PUMPING THE DEVICE. TROUBLESHOOTING WAS PERFORMED, AND THE PHYSICIAN WAS UNSUCCESSFUL IN INFLATING THE CYLINDERS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840029 ↗
• InjuryMar 31, 2026Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN IN THE GROIN AREA. A SURGICAL PROCEDURE WAS PERFORMED, AS THE PHYSICIAN SUSPECTED THAT THE RESERVOIR WAS THE SOURCE OF THE PAIN; THEREFORE, THE COMPONENT WAS REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 24745193 ↗
• InjuryMar 31, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED INFLATION DIFFICULTIES, NOT INFLATING BEYOND APPROXIMATELY 50%. DURING THE SUBSEQUENT SURGICAL PROCEDURE, A FLUID LOSS WAS IDENTIFIED. THE PUMP WAS REMOVED AND REPLACED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744519 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  PLEASE UPDATE THE COMPLAINT SUMMARY AND B5 TO THE FOLLOWING: IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO ACTIVATE THE DEVICE DURING THE POSTOPERATIVE APPOINTMENT DUE TO PERSISTENT SWELLING. ONE MONTH LATER, IT WAS NOTED THAT THE DEVICE REMAINED DIFFICULT TO CYCLE. THE PHYSICIAN LATER OBSERVED THAT THE PATIENT HAD SCARRING AROUND THE PUMP, WHICH CONTRIBUTED TO THE DIFFICULTY CYCLING THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED 98 DAYS AFTER THE DEVICE WAS ORIGINALLY IMPLANTED, DURING WHICH THE DEVICE WAS TESTED AND FOUND TO FUNCTION AS EXPECTED. HOWEVER, IT WAS NOTED THAT THE PATIENT HAD AN ALMOST KELOID-LIKE SCAR AROUND THE PUMP, POTENTIALLY RELATED TO THE COATING ON THE PUMP, ALTHOUGH THIS WAS NOT CONFIRMED. AS A RESULT, THE PUMP WAS RELOCATED TO THE OTHER HEMISCROTUM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Scar Tissue; Swelling/ Edema

  MAUDE report 24613083 ↗
• InjuryMar 11, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS BUCKLING AT MID SHAFT AND CAUSING CURVATURE. THE ISSUE WAS ATTRIBUTED TO OVERSIZING. AS A RESULT, THE CYLINDERS WERE EXPLANTED AND REPLACED WITH SHORTER ONES. THE CORPORA WERE REPAIRED WITH GRAFTS PLACED OVER WEAKENED AREAS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24570312 ↗
• InjuryMar 10, 2026Inflation Problem; Migration

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS UNABLE TO PUMP THE DEVICE ENTIRELY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THERE WAS DISTAL CROSS OVER NOTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24565335 ↗
• InjuryFeb 5, 2026Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE DUE TO DIFFICULTY CYCLING FLUID INTO THE CYLINDERS WHILE USING THE TENACIO PUMP. THE PHYSICIAN REPORTED THAT THE DEVICE WAS ABLE TO CYCLE FLUID APPROPRIATELY WHEN ASSESSED IN THE OPERATING ROOM. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE TENACIO PUMP WAS REMOVED AND REPLACED WITH AN MS PUMP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268145 ↗
• InjuryDec 30, 2025Nonstandard Device; Malposition of Device; Nonstandard Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE DUE TO DIFFICULTY LOCATING THE PUMP AND DISCOMFORT RELATED TO PALPABLE TUBING BENEATH THE SKIN. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS REPOSITIONED TO A NEW SCROTAL LOCATION, AND THE RESERVOIR WAS REMOVED AND REPLACED INTO A NEW SPACE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 23927711 ↗
• InjuryDec 30, 2025Inflation Problem; Mechanical Problem; Failure to Deflate; Inflation Problem; Mechanical Problem; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE BECAUSE THE DISTAL TIPS WERE UNEVEN AND HE DID NOT LIKE THE TENACIO PUMP. ADDITIONALLY, THE PUMP WAS DIFFICULT TO INFLATE AND DEFLATE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS, AND THE TENACIO PUMP WAS REPLACED WITH AN MS PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924846 ↗
• InjuryDec 26, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT MAINTAIN ERECTION AND AUTO DEFLATED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897634 ↗
• InjuryDec 26, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING ISSUES WITH PUMPING, AS THE PATIENT WAS UNABLE TO FULLY INFLATE THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896109 ↗
• InjuryNov 7, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IS HAVING DIFFICULTY INFLATING THE DEVICE. THE PHYSICIAN STATED THAT THE PUMP WAS EXTREMELY DIFFICULT TO SQUEEZE AND THAT EVEN WHEN IT WAS PRESSED IT DID NOT APPEAR TO BE MOVING MUCH FLUID IF ANY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497263 ↗
• InjuryOct 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO ACHIEVE A RIGID ERECTION. UPON EVALUATION, AN ISSUE WITH THE PUMP'S INFLATION MECHANISM WAS IDENTIFIED. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306534 ↗
• InjuryOct 8, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FULLY INFLATING. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23246398 ↗
• InjuryAug 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) PRESENTED WITH INFECTION, SWELLING IN THE SCROTUM AND SLIGHT PAIN, IT WAS ALSO REPORTED THAT TUBING WAS PALPABLE NEAR SHAFT. THE IPP WAS EXPLANTED AND REPLACED WITH A TACTRA. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22893318 ↗
• MalfunctionJul 23, 2025Inflation Problem; Air/Gas in Device; Inflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DIFFICULT TO INFLATE TO IDEAL RIGIDITY AFTER FULL IMPLANTATION. INTRAOPERATIVE TESTING WITH THE PUMP EXTERNAL SHOWED NORMAL INFLATION. ONCE CONNECTED TO THE RESERVOIR AND FULLY INTERNAL, THE IMPLANT REQUIRED APPROXIMATELY 50 PUMPS TO REACH OPTIMAL RIGIDITY AND A SMALL AMOUNT OF AIR WAS OBSERVED IN THE DEVICE. THE PRESSURE RELIEF VALVE WAS RULED OUT. THE DEVICE REMAINS IMPLANTED. FURTHER DISCUSSION WITH THE PHYSICIAN IS PLANNED TO EXPLORE WHETHER A LARGER DILATION COULD HELP IMPROVE INFLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583441 ↗
• InjuryJun 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AND NOT INFLATING. THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302145 ↗
• InjuryJun 11, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS EXPERIENCED AN ISSUE WHERE THE PUMP WAS NOT FULLY INFLATING THE CYLINDERS, RESULTING IN INSUFFICIENT RIGIDITY. A REVISION SURGERY WAS PERFORMED DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22188555 ↗
• InjuryApr 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS NOT INFLATING THE CYLINDERS. THE PUMP CAN BE SQUEEZED BUT FLUID WAS NOT BEING TRANSFERRED. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE TENACIO PUMP FOR AN MS PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905112 ↗
• InjuryMar 20, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED FLUID LOSS AND RESERVOIR TUBING WAS KINKED CAUSING PATIENT TO HAVE DIFFICULTY AT PUMPING. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE RESERVOIR. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654088 ↗
• InjuryFeb 11, 2025Inflation Problem; Use of Device Problem; Defective Device; Inflation Problem; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT BY A CALL THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS PARTIALLY INFLATED. IT WAS INFORMED THE ERECTION IS HALF OF WHAT WAS NATURALLY. IT WAS ALSO MENTIONED THAT THE PATIENT HAS NOT BEEN ABLE TO INFLATE ON HIS OWN AND HAS ATTEMPTED SEVERAL TIMES FOR MORE THAN 30 MIN IN THE BATHTUB WITHOUT SUCCESS AND THE PUMP WAS HARD AS A ROCK AND HE HAS INDUCED PAIN TO HIS SCROTUM. SOME GUIDES WERE PROVIDED TO THE PATIENT ABOUT THE CORRECT DEVICE HANDLING AND THE PATIENT WAS ABLE TO INFLATE THE CYLINDERS AND DEFLATE AS WELL. IT WAS ALSO EXPLAINED DIFFERENCES BETWEEN NATURAL AND PROSTHETIC ERECTION AND REALISTIC EXPECTATIONS OF LENGTH LOSS AND THE PATIENT WAS ENCOURAGED 2-3 PER DAY TO STRETCH TISSUE AND POTENTIALLY REGAIN LOST LENGTH. ANOTHER MEDICAL APPOINTMENT WAS SUGGESTED TO CLARIFY ALL THE CONCERNS, BUT IT WAS NOT ACCEPTED.

  Patient problems: Pain

  MAUDE report 21360635 ↗
• InjuryJan 24, 2025Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS REPOSITIONED DUE TO UNSPECIFIED REASONS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233151 ↗