AMS 700 CX MS Pump 72404233-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 656 adverse event reports that list this exact device (DI 00878953009797), received between Oct 23, 2018 and Sep 28, 2026 — classified as 591 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (171 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 656 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fluid/Blood Leak; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915999 ↗
• InjurySep 25, 2026Deflation Problem

  Patient problems: Capsular Contracture

  MAUDE report 50903841 ↗
• InjurySep 23, 2026Migration

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 50874851 ↗
• InjurySep 22, 2026Migration

  It was reported that the cylinders of this Inflatable Penile Prothesis (IPP) migrated out of the original corporal incision and into the scrotum. Physician is uncertain of what might have caused it. Patient didn't show any signs of a subclinical infection, just erosion. As a result, the cylinders and pump were removed and replaced with new system, the original reservoir was left implanted. No further patient complications were reported.

  Patient problems: Erosion

  MAUDE report 50854930 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 50848916 ↗
• InjurySep 7, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50651081 ↗
• InjurySep 1, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. A surgical procedure was performed, during which fluid loss resulting from a rupture was identified. The IPP was completely replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50553506 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with extrusion of the right cylinder of the Inflatable Penile Prosthesis (IPP) through the corporotomy site. A surgical procedure was performed during which the IPP was explanted. The patient was subsequently remeasured, and a new IPP system was implanted. No device issue was reported. No additional patient complications were reported.

  Patient problems: Erosion

  MAUDE report 50488029 ↗
• MalfunctionAug 20, 2026Collapse; Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351109 ↗
• InjuryAug 18, 2026Material Puncture/Hole; Insufficient Device Problem Information

  It was reported that the patient with an Inflatable Penile Prosthesis (IPP) experienced distal cylinder erosion through the urethra following a pump revision procedure. A revision procedure was performed during which the device was explanted. No patient complications were reported.

  Patient problems: Erosion; Perforation

  MAUDE report 50310131 ↗
• InjuryAug 14, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255888 ↗
• InjuryAug 13, 2026Mechanical Problem; Malposition of Device

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) was dissatisfied with the results of the initial implant procedure because the device was not functioning properly. A revision surgery was performed, during which a crossover was confirmed. It was determined that, during the original implantation, the distal end of the left cylinder had been placed in the same corporal cavity as the right cylinder. The preconnected was explanted and replaced. No patient complications were reported.

  Patient problems: Perforation

  MAUDE report 50240195 ↗
• InjuryAug 5, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  It was reported that this Inflatable Penile Prosthesis (IPP) was not inflating. Upon inspection, damage to the outer silicone layer of the cylinders and associated fluid loss were identified. As a result, the device was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148095 ↗
• InjuryAug 4, 2026Deflation Problem; Inflation Problem

  It was reported that during the implantation procedure of this Inflatable Penile Prosthesis (IPP), the device was not filling or deflating properly during the activation process. The physician elected to remove the device and replace it with a new alternate device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136318 ↗
• InjuryJul 22, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. DURING A SURGICAL PROCEDURE, THE DEVICE WAS EXPLANTED, AND IT WAS OBSERVED THAT THE RESERVOIR WAS EMPTY. EXAMINATION ALSO REVEALED A SMALL TEAR IN THE RIGHT CYLINDER NEAR THE CORPOROTOMY SITE; HOWEVER, IT COULD NOT BE DETERMINED WHETHER THIS TEAR WAS THE SOURCE OF THE FLUID LOSS. THE ENTIRE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25908779 ↗
• InjuryJul 21, 2026Inflation Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WOULD NOT INFLATE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED TEARS IN BOTH CYLINDERS. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THE RESERVOIR WAS RETAINED AND USED WITH THE REPLACEMENT CYLINDERS AND PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892856 ↗
• InjuryJul 20, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WOULD NOT CYCLE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN IDENTIFIED A HOLE AT THE CONNECTION OF THE EXIT TUBING AND THE CYLINDER, RESULTING IN A FLUID LEAK. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883636 ↗
• InjuryJul 20, 2026Migration; Unintended Deflation

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WOULD NOT MAINTAIN RIGIDITY SUFFICIENT FOR PENETRATION, WITH THE PATIENT REPORTING THAT THE DEVICE DEFLATED AFTER 5 TO 10 MINUTES OF INTERCOURSE. THE PATIENT SUBSEQUENTLY REPORTED LEFTWARD CURVATURE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED CYLINDER CROSSOVER AND NOTED THAT BOTH CYLINDERS WERE LOCATED IN THE DISTAL RIGHT CORPORAL BODY. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Deformity/ Disfigurement; Unspecified Tissue Injury

  MAUDE report 25882167 ↗
• MalfunctionJul 15, 2026Deflation Problem

  IT WAS REPORTED THAT DURING A SURGICAL IMPLANTATION PROCEDURE FOR AN INFLATABLE PENILE PROSTHESIS (IPP), DURING TEST INFLATION, THE SURGEON WAS UNABLE TO DEFLATE THE DEVICE WITHOUT CONTINUOUSLY PRESSING THE RELEASE BUTTON. STANDARD TROUBLESHOOTING WAS PERFORMED, AND ALTHOUGH THE DEVICE COULD EVENTUALLY BE DEFLATED, THE SURGEON ELECTED NOT TO USE THE IMPLANT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834079 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED GLANS NECROSIS, WHICH BEGAN SHORTLY AFTER THE IMPLANT WAS PLACED. THE GLANS WAS NOTED TO BE TURNING BLACK, LEADING TO THE IDENTIFICATION OF NECROSIS, WHICH WAS DIAGNOSED VIA VISUAL EXAMINATION. THE PATIENT WAS CONSIDERED PREDISPOSED TO THIS CONDITION DUE TO COMPROMISED BLOOD FLOW. NO DEVICE ISSUES WERE REPORTED. A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE IPP. NO NEW IPP WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Necrosis

  MAUDE report 25833744 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25765585 ↗
• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN. DURING A REVISION SURGERY, THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 25757225 ↗
• InjuryJul 8, 2026Deflation Problem; Mechanical Problem; Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A DEVICE THAT WAS NO LONGER DEFLATING AND REMAINED IN AN INFLATED STATE FOR OVER ONE WEEK. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR TUBING WAS LINKED AND BOTH CYLINDERS HAD HERNIATED. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Perforation

  MAUDE report 25751088 ↗
• MalfunctionJul 2, 2026Signal Artifact/Noise; Nonstandard Device; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. DEVICE DATA WAS SENT TO RHYTHMCARE FOR REVIEW. DATA REVIEW DETERMINED THERE WAS OVERSENSING AND UNDERSENSING OF THE REPORTED NOISE. RHYTHMCARE THEN PROVIDED FURTHER TROUBLESHOOTING OPTIONS TO BE CONSIDERED AT THE NEXT FOLLOW UP APPOINTMENT. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Impaired Healing; Localized Skin Lesion; Nerve Damage; No Clinical Signs, Symptoms or Conditions; Numbness; Pain; Perforation; Swelling/ Edema

  MAUDE report 25699800 ↗
• InjuryJun 26, 2026Break; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INABILITY TO INFLATE THE DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS AND IDENTIFIED THAT THE ORIGINAL IMPLANT HAD A SUTURE STRIKE IN THE RIGHT CYLINDER. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638451 ↗