AMS 700 CX MS Pump 72404232-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 533 adverse event reports that list this exact device (DI 00878953009780), received between Oct 23, 2018 and Sep 25, 2026 — classified as 470 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (137 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 25 most recent of 533 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Collapse; Inflation Problem; Mechanical Problem; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898460 ↗
• InjurySep 25, 2026Collapse; Inflation Problem; Material Puncture/Hole; Use of Device Problem; Air/Gas in Device

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) could not inflate his device. During revision surgery, a flat pump, the presence of air within the pump, a hole in the cylinder, and inflation difficulties were identified. The patient stated that he may have forcefully compressed both the inflation and deflation buttons simultaneously and believed this may have damaged the pump. The physician considered the event to be related to user operation. As a result, the cylinders and pump were explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893257 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  It was reported that, during this Inflatable Penile Prosthesis (IPP) implant procedure, a urethral injury occurred; therefore, a Tactra device was implanted instead. Some time later, the malleable device was removed and replaced with the intended IPP. No further patient complications were reported.

  Patient problems: Perforation

  MAUDE report 50870131 ↗
• InjurySep 23, 2026Inflation Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) developed a hematoma following the original implantation procedure. The resulting scrotal swelling prevented the patient from effectively operating the device and locating the deflation button. As a result, the pump was explanted and repositioned within the scrotum to facilitate easier use. No further patient complications were reported.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 50869029 ↗
• InjurySep 21, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848957 ↗
• InjurySep 21, 2026Nonstandard Device

  It was reported that patient was experiencing pain in the penis and abdomen with the Inflatable Penile Prosthesis (IPP). As a result, the device was explanted and replaced with a Tactra. No further patient complications were reported.

  Patient problems: Pain

  MAUDE report 50843031 ↗
• InjurySep 8, 2026Nonstandard Device

  It was reported that patient was dissatisfied with his Inflatable Penile Prothesis (IPP). As a result, the cylinders, pump and rear tips were explanted, resized and replaced. The originally implanted reservoir was preserved. No further patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668293 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 50650367 ↗
• InjurySep 1, 2026Deflation Problem; Migration

  It was reported that the patient experienced bleeding approximately three weeks after implantation of the Inflatable Penile Prosthesis (IPP). The bleeding subsequently resulted in tissue scarring, causing the pump to become high riding and fixed within the surrounding scar tissue. As a result, the pump was unable to function properly, and the device could not be deflated. A surgical procedure was performed during which the pump was explanted, scar tissue was removed from the scrotum, and a new Tenacio pump was implanted. The new pump was connected to the previously implanted cylinders, tested, and confirmed to be functioning properly. No additional patient complications were reported.

  Patient problems: Capsular Contracture; Hemorrhage/Blood Loss/Bleeding; Scar Tissue

  MAUDE report 50553500 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50351113 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50333747 ↗
• InjuryAug 19, 2026Inflation Problem; Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329763 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient implanted with an Inflatable Penile Prosthesis (IPP) experienced swelling at the scrotal and infrapubic incision sites. The patient was initially treated with antibiotics. Subsequently, a small opening developed at the scrotal incision site, accompanied by noticeable discharge. The opening was reported to have enlarged compared to the previous evaluation. As a result, a surgical procedure was performed to explant the IPP and replace it with a Tactra device. No device issues were identified. The patient is expected to be reevaluated for reimplantation of an IPP once the infection has completely resolved. The patient was also sent home with antibiotics. No additional patient complications were reported.

  Patient problems: Purulent Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 50317577 ↗
• InjuryAug 14, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260538 ↗
• InjuryAug 12, 2026Inadequacy of Device Shape and/or Size

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225874 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50223083 ↗
• InjuryAug 3, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that this Inflatable Penile Prosthesis (IPP) was no longer working. Upon inspection, a fracture to the cylinder was noticed. As a result, the device was explanted. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115154 ↗
• InjuryJul 30, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size; Migration

  It was reported that this Inflatable Penile Prosthesis (IPP) was displaced. The patient complained of a significant discrepancy between the right and left corporal cylinders, as well as difficulty operating the device. Magnetic resonance imaging (MRI) was performed and demonstrated proximal erosion of the right cylinder extending posteriorly within the perineum beyond the crus of the corpora. The distal aspect of the left cylinder terminated approximately 2.0 cm proximal to the right cylinder and did not reach the glans. The patient experienced floppy glans. The MRI also suggested possible buckling of both cylinders within the penile shaft. A surgical procedure was performed, during which the IPP was removed. No further patient complications were reported.

  Patient problems: Deformity/ Disfigurement; Erosion

  MAUDE report 50086963 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) experienced a urethral injury. A revision surgery was performed, during which the physician explanted the device and implanted a Tactra device. The Tactra device was implanted to allow the patient to heal before implantation of a new Inflatable Penile Prosthesis (IPP). There were no further patient complications.

  Patient problems: Perforation

  MAUDE report 50037836 ↗
• InjuryJul 8, 2026Migration

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS RIDING TOO HIGH AND THE TUBING WAS LOCATED TOO SUPERFICIALLY. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25756503 ↗
• InjuryJul 6, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) NOTICED THAT THE GLANS PENIS WAS POSITIONED AT APPROXIMATELY A 90-DEGREE ANGLE. THE PATIENT INITIALLY THOUGHT THAT THE CATHETER WAS PULLING ON THE DISTAL END OF THE PENIS. HOWEVER, AFTER THE CATHETER WAS REMOVED, THE GLANS REMAINED IN THE SAME POSITION. THE PATIENT ALSO NOTED THAT THE CYLINDERS DID NOT EXTEND TO THE TIP OF THE PENIS. AT A FOLLOW-UP APPOINTMENT, THE PHYSICIAN AGREED THAT THE APPEARANCE WAS ABNORMAL. AN APPOINTMENT WAS SCHEDULED FOR MAGNETIC RESONANCE IMAGING (MRI) TO FURTHER EVALUATE THE CONDITION AND DETERMINE APPROPRIATE MANAGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25727660 ↗
• InjuryJul 3, 2026Collapse; Inflation Problem; Mechanical Problem; Migration; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PUMP WAS NOT FUNCTIONING PROPERLY AND THAT THE DEVICE WAS EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A LARGE AIR BUBBLE WAS IDENTIFIED WITHIN THE ORIGINAL PUMP. ADDITIONALLY, THE PUMP WAS FOUND TO BE INVERTED AND ENCAPSULATED BY SURROUNDING TISSUE. EROSION WAS ALSO OBSERVED. THE PUMP WAS REMOVED, AND THE AIR WAS EVACUATED FROM THE SYSTEM. A NEW PUMP WAS IMPLANTED, AND THE RESERVOIR WAS REFILLED WITH FRESH SALINE. THE NEW PUMP WAS CONNECTED TO THE EXISTING SYSTEM AND TESTED MULTIPLE TIMES, DEMONSTRATING SATISFACTORY FUNCTION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Capsular Contracture; Erosion

  MAUDE report 25707127 ↗
• InjuryJun 30, 2026Deflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT DEFLATING. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673599 ↗
• MalfunctionJun 8, 2026Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THIS INFLATABLE PENILE PROSTHESIS (IPP), INTRAOPERATIVE MODELING WAS PERFORMED FOLLOWING PLACEMENT OF THE IMPLANT. THE TUBING CONNECTED TO THE PUMP AND CYLINDERS WAS CLAMPED DURING MODELING AND SUBSEQUENTLY UNCLAMPED PRIOR TO DEVICE TESTING WITH CONNECTION TO A SURROGATE RESERVOIR. DURING FUNCTIONAL TESTING, NO TACTILE FEEDBACK WAS OBSERVED UPON PUMP ACTUATION, INCLUDING ABSENCE OF BUZZING OR VIBRATION, AND THE PUMP DID NOT FUNCTION AS INTENDED, AS FLUID DID NOT TRANSFER INTO OR OUT OF THE PUMP, RESULTING IN NO INFLATION OR DEFLATION. TROUBLESHOOTING ATTEMPTS, INCLUDING REPEATED INFLATION AND DEFLATION ATTEMPTS AND ACTUATION OF THE PUMP SIDEBARS, WERE UNSUCCESSFUL. THE SURROGATE RESERVOIR WAS CONFIRMED TO BE PROPERLY FILLED AND CONNECTED PRIOR TO TESTING. NO AIR WAS OBSERVED IN THE DEVICE. NO HOLE OR DAMAGE WAS IDENTIFIED IN THE PUMP; HOWEVER, FOLLOWING COMPRESSION, THE PUMP BULB REMAINED DEFLATED WITH AN INDENTATION AND SLOWLY REFILLED, WITH FLUID ATTEMPTING TRANSFER TO THE CYLINDERS. THE DEVICE WAS REMOVED AND REPLACED WITH AN ALTERNATE DEVICE DURING THE SAME PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437446 ↗
• InjuryJun 5, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED THE DEVICE WAS NOT WORKING PROPERLY AND DIFFICULT TO INFLATE. AS A RESULT, THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407759 ↗