AMS 700 CX MS Pump 72404238Recalls & reported problems

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 00878953003511), received between Nov 1, 2018 and Sep 30, 2026 — classified as 279 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (108 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 312 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947387 ↗
• MalfunctionSep 23, 2026Deflation Problem; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872606 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient implanted with this Inflatable Penile Prosthesis (IPP) returned following discharge due to painful urination, hematuria, and penoscrotal swelling. A cystoscopy was performed and a cylinder was observed in the distal urethra. A surgical procedure was performed during which further examination noted both the right and left cylinders had perforated the urethra. The device was removed, a betadine washout was performed, a foley catheter was placed and the patient was given antibiotics. No further patient complications were reported.

  Patient problems: Dysuria; Hematuria; Swelling/ Edema

  MAUDE report 50361971 ↗
• InjuryAug 20, 2026Deflation Problem; Inflation Problem; Inadequacy of Device Shape and/or Size

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50360034 ↗
• InjuryAug 17, 2026Inflation Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) was unable to inflate. A surgical procedure was performed during which the entire device was explanted and replaced. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50284771 ↗
• InjuryAug 13, 2026Collapse; Fluid/Blood Leak; Inflation Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) exhibited inflation issues that were suspected to be related to fluid loss. During the revision procedure, the pump was found to be collapsed. No air was observed within the system, and no apparent leak was identified upon device removal or during evaluation. The source of the fluid loss could not be determined intraoperatively. The IPP was replaced, and no patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240196 ↗
• InjuryAug 7, 2026Inflation Problem; Mechanical Problem; Migration

  Patient problems: Discomfort

  MAUDE report 50177546 ↗
• InjuryJul 22, 2026Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE FOR THIS INFLATABLE PENILE PROSTHESIS (IPP), THE PHYSICIAN REPORTEDLY PUNCTURED A CYLINDER WITH A SUTURE NEEDLE WHILE CLOSING THE INCISION, RESULTING IN A HOLE IN THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905519 ↗
• InjuryJul 20, 2026Patient-Device Incompatibility; Failure to Deflate

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A TOUGH TIME DEFLATING HIS DEVICE. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED, AND THE RESERVOIR WAS DRAINED AND RETAINED. A NEW IPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876920 ↗
• InjuryJul 14, 2026Degraded; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO INFLATE THE DEVICE. UPON INSPECTION, A RIGHT SIDED CORPORAL ANEURYSM WAS IDENTIFIED. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR WAS LEFT IN PLACE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820979 ↗
• InjuryJul 8, 2026Deflation Problem; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT INFLATE 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 25757035 ↗
• InjuryJun 30, 2026Fluid/Blood Leak; Material Puncture/Hole; Human-Device Interface Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISSATISFACTION WITH DEVICE PUMP. UPON INSPECTION, A MINIMAL FLUID IN THE RESERVOIR WAS NOTICED. THE PHYSICIAN SUSPECTED A HOLE IN THE RESERVOIR OR CYLINDERS, POSSIBLY DUE TO SUTURE PLACEMENT OR UNRELATED SURGICAL PROCEDURE. AS A RESULT, THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THE RESERVOIR WAS DRAINED, RETAINED IN PATIENT AND A NEW ONE WAS PLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673512 ↗
• InjuryJun 25, 2026Inflation Problem; Nonstandard Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630756 ↗
• InjuryJun 17, 2026Mechanical Problem; Nonstandard Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535454 ↗
• InjuryJun 9, 2026Fluid/Blood Leak; Nonstandard Device

  It was reported that this Inflatable Penile Prosthesis (IPP) had fluid loss. A surgical procedure was performed during which the device was explanted and replaced. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448738 ↗
• InjuryMay 27, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Human-Device Interface Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INABILITY TO PUMP THE DEVICE. DURING A REVISION SURGERY, THE PHYSICIAN IDENTIFIED A STICKY PUMP AND A FLUID LEAK IN THE SYSTEM, ASSOCIATED WITH A HOLE IN THE RESERVOIR. THE PUMP AND RESERVOIR WERE EXPLANTED AND REPLACED, WHILE THE CYLINDERS REMAINED IMPLANTED AND FUNCTIONAL. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311431 ↗
• InjuryMay 6, 2026Inflation Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) COULD BE PUMPED; HOWEVER, THE DEVICE EXHIBITED AUTO-INFLATION ISSUES, AND THE CYLINDERS COULD NOT BE FULLY INFLATED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP, DURING WHICH IT WAS IDENTIFIED THAT THE CYLINDERS MAY HAVE BEEN OVERSIZED. MEDICAL STAFF SUSPECTED THAT THE ORIGINAL MEASUREMENT MAY HAVE BEEN INCORRECT BY APPROXIMATELY 3-4 CM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107191 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED FEVER AND SCROTAL PAIN AND SWELLING. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH AN INFECTION LOCATED IN THE SCROTUM WAS IDENTIFIED. THE IPP WAS REMOVED AND REPLACED WITH A MALLEABLE DEVICE. ADDITIONALLY, ANTIBIOTIC WAS PROVIDED. NO DEVICE ISSUES WERE IDENTIFIED, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24879515 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH LEFT CYLINDER EROSION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN EXPLANTED THE LEFT CYLINDER AND IMPLANTED AN 11 MM TACTRA IN THE RIGHT SIDE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Erosion

  MAUDE report 24747198 ↗
• InjuryMar 18, 2026Collapse; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM DUE TO A FLUID LOSS. IT WAS REPORTED THAT PUMP BULB REMAINED FLAT WHEN TRYING TO INFLATE. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629953 ↗
• InjuryMar 11, 2026Fluid/Blood Leak; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS. 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 24575235 ↗
• InjuryFeb 24, 2026Inflation Problem; Mechanical Problem; Unintended Deflation

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING PUMP. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE PUMP WAS NOT FULLY INFLATING AND WAS AUTOMATICALLY DEFLATING. WHEN ATTEMPTING TO PUMP, AFTER THREE TO FOUR PUMPS, THE PUMP WOULD BECOME FIRM, AND THE PHYSICIAN WAS UNABLE TO PUMP FURTHER. THE PHYSICIAN ALSO STATED THAT NO AIR WAS OBSERVED IN THE DEVICE, AND THE BULB DID NOT REMAIN FLAT DURING ASSESSMENT. THE PATIENT'S IMPLANT WAS NOT ACHIEVING FULL ERECTION. INTRAOPERATIVELY, THE RESERVOIR WAS TESTED AND CONTAINED THE CORRECT AMOUNT OF FLUID (100 CC), AND NO LEAKS WERE IDENTIFIED; THEREFORE, THE PHYSICIAN DECIDED TO REPLACE ALL COMPONENTS EXCEPT THE RESERVOIR. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434613 ↗
• InjuryFeb 23, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. UPON INSPECTION, A SEVERED RESERVOIR TUBING AND ASSOCIATED FLUID LOSS WERE IDENTIFIED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422956 ↗
• InjuryFeb 10, 2026Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308009 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED DISTAL EROSION OF THE RIGHT CYLINDER. THE PHYSICIAN REMOVED THE IPP SYSTEM AND IMPLANTED THE LEFT SIDE WITH A TACTRA PROSTHESIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 24299924 ↗