AMS 700 MS Pump 72404310Recalls & reported problems

Summary

The FDA's MAUDE database contains 992 adverse event reports that list this exact device (DI 00878953003986), received between Oct 5, 2018 and Sep 25, 2026 — classified as 975 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (648 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 992 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) developed an infection following the most recent surgical procedure. As a result, the device was explanted. No further patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50893083 ↗
• InjurySep 24, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890392 ↗
• InjurySep 23, 2026Mechanical Problem

  It was reported that the pump of this Inflatable Penile Prosthesis (IPP) was not working properly. As a result, the device was explanted and replaced. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871153 ↗
• InjurySep 21, 2026Collapse; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848082 ↗
• InjurySep 2, 2026Collapse

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) exhibited a non rebounding pump. Troubleshooting of the device outside the patient was unsuccessful in restoring normal pump function. A surgical procedure was subsequently performed during which the pump was replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569008 ↗
• InjurySep 2, 2026Mechanical Problem

  It was reported that a patient implanted with an Inflatable Penile Prosthesis (IPP) experienced scrotal pain. As a result, a surgical intervention was performed. During the procedure, the pump position was adjusted, and the Rear Tip Extender (RTE) was replaced. No additional information was provided.

  Patient problems: Pain

  MAUDE report 50554692 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient implanted with this Inflatable Penile Prosthesis (IPP) experienced a scrotal and penile infection. A surgical procedure was performed during which the device was fully explanted and replaced. The infection was treated with disinfection, debridement, and drainage. No device related issues were identified. No additional patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50488107 ↗
• InjuryAug 24, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50415983 ↗
• InjuryAug 19, 2026Mechanical Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) pump was not functioning properly, as it could not be pressurized, preventing penile erection. As a result, a surgical procedure was performed to explant the IPP. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326179 ↗
• InjuryAug 19, 2026Mechanical Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) pump was not functioning properly, as it could not be pressurized, preventing penile erection. As a result, a surgical procedure was performed to explant the IPP. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50317576 ↗
• InjuryAug 17, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient went to the clinic because this Inflatable Penile Prosthesis (IPP) was not working properly. Two weeks later, a surgical procedure was performed, during which a crack in the pump connecting tube was identified. The pump was removed and replaced. The cause of crack in the connecting tube was not detailed by the hospital. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278453 ↗
• InjuryAug 14, 2026Inflation Problem; Mechanical Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly because the pump could not be pressed, preventing penile erection. A surgical procedure was performed during which the pump was replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255899 ↗
• InjuryAug 4, 2026Mechanical Problem

  It was reported that an Inflatable Penile Prosthesis (IPP) stopped functioning. The patient experienced tissue fluid drainage from the surgical wound and the pump area. The pump became exposed, and the cylinder extruded. Subsequently, the patient was hospitalized for treatment. Some time later, all device components were removed. Once the patient has recovered, a new IPP will be implanted. No further patient complications were reported.

  Patient problems: Erosion; Fluid Discharge

  MAUDE report 50127948 ↗
• InjuryJul 20, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE PUMP CONNECTING TUBE WAS IDENTIFIED. THE PUMP WAS REMOVED AND REPLACED. THE CAUSE OF CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874076 ↗
• InjuryJul 14, 2026Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820941 ↗
• InjuryJul 14, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT WAS NOT FUNCTIONING PROPERLY. TWO WEEKS LATER UPON INSPECTION A CRACK WAS FOUND IN THE PUMP CONNECTING TUBE, SO THE PUMP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25818457 ↗
• InjuryJul 13, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE PUMP CONNECTING TUBE WAS IDENTIFIED. THE PUMP WAS REMOVED AND REPLACED. THE CAUSE OF CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803793 ↗
• InjuryJul 7, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY, AS PRESSING THE PUMP DID NOT RESULT IN AN ERECTILE RESPONSE AND A DECREASE IN RESERVOIR FLUID VOLUME WAS NOTED. UPON INSPECTION, A HOLE IN THE TUBING NEAR THE ANTERIOR PORTION OF THE PUMP, ALONG WITH ASSOCIATED FLUID LOSS, WAS IDENTIFIED. AS A RESULT, THE PUMP WAS EXPLANTED AND REPLACED. THE RESERVOIR WAS REFILLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740371 ↗
• InjuryJul 7, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE PUMP CONNECTING TUBE WAS IDENTIFIED. THE PUMP WAS REMOVED AND REPLACED. THE CAUSE OF CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736785 ↗
• InjuryJun 30, 2026Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DIFFICULTY ACTIVATING THE DEVICE. A REVISION SURGERY WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673411 ↗
• InjuryJun 26, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN FOUND CRACK IN THE PUMP CONNECTING TUBE. THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638466 ↗
• InjuryJun 10, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  It was reported that the pump tubing of this Inflatable Penile Prosthesis (IPP) had a leakage due to a hole. The device did not work properly. As a result, the pump was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461026 ↗
• InjuryJun 9, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED A CRACK IN THE PUMP CONNECTING TUBE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451652 ↗
• InjuryMay 26, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED PUMP ISSUES. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PUMP WAS REPLACED WITH A NEW MS PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284836 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PERSISTENT PAIN FOLLOWING IMPLANTATION. DURING FOLLOW UP EVALUATION, AN INFECTION WAS IDENTIFIED IN THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH ALL COMPONENTS OF THE PROSTHESIS WERE EXPLANTED, WITH PLANS FOR REIMPLANTATION AT A LATER TIME. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25271724 ↗