AMS 700 LGX MS Pump 72404253-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00878953009827), received between Oct 29, 2018 and Jun 26, 2026 — classified as 106 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (40 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 121 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES AND EXCESSIVE PUMP RESISTANCE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE IPP WAS FULLY REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25644183 ↗
• InjuryJun 11, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that a patient's Inflatable Penile Prosthesis (IPP) was not working properly. A surgical procedure was performed, and the right cylinder was found fractured. The pump and both cylinders were replaced with a length size more suitable for the patient. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477438 ↗
• InjuryJun 11, 2026Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Material Puncture/Hole

  It was reported that this Inflatable Penile Prosthesis (IPP) was not inflating properly. Upon inspection, the cylinders appeared to show signs of material wear and structural compromise. Also, the device had fluid loss. As a result, the device was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474158 ↗
• InjuryApr 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN AND DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH AN INFECTION AND EROSION OF THE PUMP THROUGH THE SCROTUM WERE IDENTIFIED. THE IPP WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Erosion; Pain; Unspecified Infection

  MAUDE report 24867309 ↗
• InjuryMar 31, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE THAT WAS UNABLE TO INFLATE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN NOTED ABNORMAL TACTILE FEEDBACK, DESCRIBED AS A 'LOOSE SPRING' SENSATION WHEN ATTEMPTING TO INFLATE THE DEVICE. THE PUMP REFILLED BUT DID NOT TRANSFER FLUID; THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743770 ↗
• InjuryFeb 10, 2026Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES BECAUSE OF A STICKY PUMP. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303180 ↗
• InjuryFeb 9, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY, AND THE PATIENT WAS UNABLE TO INFLATE THE DEVICE. UPON INSPECTION, A BROKEN TUBE BETWEEN THE PUMP AND ONE OF THE CYLINDERS, ALONG WITH FLUID LOSS, WAS 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 24292543 ↗
• InjuryJan 28, 2026Fluid/Blood Leak; Mechanical Problem; Device Contamination with Chemical or Other Material

  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 CONFIRMED A FLUID LEAK AND THE PRESENCE OF CONTAMINATION. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24204650 ↗
• InjuryJan 12, 2026Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED INFLATION ISSUES, AS THE DEVICE DID NOT CYCLE AND NO RESPONSE OCCURRED WHEN PUMPED, PREVENTING THE PATIENT FROM ACHIEVING AN ERECTION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH AIR AND A HOLE WAS OBSERVED IN THE DEVICE. THE IPP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046961 ↗
• InjuryJan 7, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH FLUID LOSS WAS CONFIRMED AT THE MID-CYLINDER AREA, DUE TO A HOLE. THE IPP WAS REPLACED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995199 ↗
• InjuryDec 19, 2025Degraded; Degraded

  IT WAS REPORTED THAT A REPLACEMENT SURGICAL PROCEDURE WAS PERFORMED DUE TO A LEFT CYLINDER ANEURYSM IN AN INFLATABLE PENILE PROSTHESIS (IPP). A NEW PRE-CONNECTED CYLINDER AND REAR TIP EXTENDER WERE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848702 ↗
• InjuryNov 19, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) FELT A POP AND THE DEVICE WAS NOT WORKING AS EXPECTED. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE OUTER LAYERS OF BOTH CYLINDERS WERE FOUND TO BE TORN. THEREFORE, THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599062 ↗
• InjuryNov 10, 2025Inflation Problem; Mechanical Problem; Nonstandard Device; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER FUNCTIONING, THE DEVICE PRESENTED INFLATION ISSUES, AND THE PUMP WASN'T MOVING FLUID. 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 23510488 ↗
• InjuryOct 30, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device; Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS AND INFLATION ISSUES. DURING THE SURGICAL PROCEDURE, A SMALL PINHOLE-SIZED LEAK WAS IDENTIFIED IN THE LEFT CYLINDER. ADDITIONALLY, AIR WAS OBSERVED WITHIN THE DEVICE, AND THE PUMP BULB REMAINED COLLAPSED. THE ENTIRE PROSTHETIC SYSTEM WAS EXPLANTED AND REPLACED WITH A NEW IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425680 ↗
• InjuryAug 25, 2025Migration; Migration

  IT WAS REPORTED THAT THE CYLINDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED TO THE SCROTUM. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP, RE-MEASURED AND REPLACED WITH A SMALLER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886154 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE SYSTEM. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 22027602 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HERNIA. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM AWAY FROM HERNIA AREA. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Hernia

  MAUDE report 21964561 ↗
• InjuryApr 25, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO CURRENT TUBING BEING TOO SHORT. THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909151 ↗
• InjuryMar 14, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS NO LONGER WORKING AS INTENDED. DURING REVISION SURGERY, THE PHYSICIAN CONFIRMED THAT AFTER REMOVING THE OLD PUMP ONE OF THE CYLINDERS HAD A HOLE AND THE OUTER SHEATH WAS TORN. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW IPP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607062 ↗
• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT, ENROLLED IN A CLINICAL STUDY, WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DYSURIA ON THE SAME DAY THE DEVICE WAS IMPLANTED; THEREFORE, THE HOSPITALIZATION WAS PROLONGED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Dysuria

  MAUDE report 21322318 ↗
• InjuryDec 12, 2024Inflation Problem; Defective Device; Inflation Problem; Defective Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FILLING PROPERLY AS IT WAS NOT RETAINING THE SALINE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH RESERVOIR, PUMP AND ONE CYLINDER WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915366 ↗
• MalfunctionNov 7, 2024Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED INFLATING AS INTENDED. THE PATIENT SUSPECTS THERE IS NO FLUID IN THE DEVICE, AND IT HAS LOST ITS INTEGRITY. THE PATIENT WAS PROVIDED WITH TROUBLESHOOTING INSTRUCTIONS AND IS PLANNING TO CONSULT WITH THEIR PHYSICIAN. THERE HAS BEEN NO SURGICAL INTERVENTION OR PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630289 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AS EXPECTED BECAUSE THERE WAS AN ISSUE WITH THE PUMP AND FLUID REFILL, ALSO THERE WAS A SLIGHT FLUID LOSS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464720 ↗
• InjurySep 24, 2024Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THERE WAS A CAPSULE AROUND THE PUMP, PREVENTING THE COMPONENT TO WORK PROPERLY. THE PUMP WAS REMOVED, AND A NEW ONE WAS IMPLANTED IN A DIFFERENT LOCATION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Capsular Contracture

  MAUDE report 20294275 ↗
• InjurySep 18, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT CYCLING WELL DUE TO FLUID LOSS AT THE CONNECTION SITE OF THE TUBING. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249489 ↗