AMS 700 CX MS Pump 72404237Recalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 00878953003504), received between Oct 10, 2018 and Sep 30, 2026 — classified as 245 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (75 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 262 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Human-Device Interface Problem

  Patient problems: Swelling/ Edema

  MAUDE report 50954695 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma; Pain; Purulent Discharge; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 50651633 ↗
• InjuryAug 31, 2026Fluid/Blood Leak; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) exhibited fluid loss. During a revision procedure, a tubing break was identified as the cause of the loss of fluid. The IPP was removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515518 ↗
• InjuryAug 10, 2026Inflation Problem; Inadequacy of Device Shape and/or Size

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced difficulty inflating the device. The patient stated that since beginning to cycle the device, it would only inflate a small amount, and the erection was very small. The physician recommended continued cycling; however, after further evaluation, replacement surgery was recommended. Several days later, the device was explanted and replaced. No additional information was provided.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema; Urinary Incontinence

  MAUDE report 50196864 ↗
• InjuryAug 7, 2026Inflation Problem; Mechanical Problem; Malposition of Device; Human-Device Interface Problem

  It was reported that the patient implanted with an Inflatable Penile Prosthesis (IPP) experienced difficulty operating the pump and inadequate inflation of the device. A revision procedure was performed, during which the existing pump was explanted and replaced with a tenacio pump. The physician suspected that the reservoir placement and pump location may have contributed to the reported issue. The age of the device was also considered a contributing factor. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176963 ↗
• InjuryJul 2, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A CYLINDER RUPTURE. 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 25700132 ↗
• InjuryJun 19, 2026Migration

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) TUBING BECAME EXPOSED AT THE INFRAPUBIC INCISION SITE FOLLOWING THE ORIGINAL SURGERY. A FEW MONTHS LATER, THE PATIENT DEVELOPED SWELLING AND BACTERIAL INFECTION IN THE AREA OF THE EXPOSED TUBING. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA AS A PLACEHOLDER. THE INCISION SITE WAS IRRIGATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Bacterial Infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25563842 ↗
• InjuryMay 13, 2026Fluid/Blood Leak; Mechanical Problem; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN IDENTIFIED FLUID LOSS AND AIR IN THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162939 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A BACTERIAL INFECTION AT THE INCISION SITE. ALL IPP COMPONENTS WERE REMOVED, THE AFFECTED AREA WAS FLUSHED, AND CYLINDERS WERE PLACED IN TO ALLOW THE TISSUE TO HEAL FOR A REPLACEMENT SURGERY AT A LATER DATE. NO DEVICE ISSUES OR ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 25081196 ↗
• InjuryApr 24, 2026Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AN INFLATION PROBLEM. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981809 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN IN THE DISTAL TIPS. THE CYLINDERS AND THE PUMP WERE REMOVED, THE PHYSICIAN THEN REDILATED OUTSIDE OF THE ORIGINAL CAPSULES AND REPLACED THE CYLINDERS AND THE PUMP. THERE WERE NO DEVICE ISSUES OR ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Implant Pain

  MAUDE report 24755670 ↗
• InjuryMar 31, 2026Inflation Problem; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO ACHIEVE FULL INFLATION. UPON INSPECTION, THE LEFT CYLINDER APPEARED SIGNIFICANTLY SHORTENED WITHIN THE LEFT CORPORA. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A LARGER ONE. A SMALL AMOUNT OF MODELING WAS PERFORMED, BUT THE CURVATURE REMAINED UNDER 30 DEGREES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747179 ↗
• InjuryMar 16, 2026Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY AS IT PRESENTED INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612473 ↗
• InjuryJan 20, 2026Collapse; Inflation Problem; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN, DISCOMFORT, AND DISSATISFACTION DUE TO THE DEVICE NOT INFLATING PROPERLY. THE PHYSICIAN REPORTED THAT THE PUMP BULB REMAINED COLLAPSED AND DID NOT ALLOW SATISFACTORY INFLATION OF THE PROSTHESIS. TROUBLESHOOTING MANEUVERS WERE ATTEMPTED WITHOUT RESOLUTION. THE PHYSICIAN BELIEVED THAT THIS MECHANICAL ISSUE MAY HAVE CONTRIBUTED TO THE PAIN AND DISCOMFORT OF THE PATIENT. THE OPTION OF A REVISION OR REPLACEMENT SURGERY WILL BE EVALUATED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 24117377 ↗
• InjuryJan 9, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A FALL, AFTER WHICH THE PATIENT DEVELOPED INTERMITTENT GROIN PAIN AND WAS UNABLE TO LOCATE THE PUMP. MEDICATION WAS PRESCRIBED; HOWEVER, THE SYMPTOMS DID NOT RESOLVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24023219 ↗
• InjuryDec 11, 2025Mechanical Problem; Nonstandard Device; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH AN INABILITY TO ACTIVATE THE PUMP. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT, AFTER INSPECTING THE DEVICE, THE RESERVOIR WAS STILL HOLDING FLUID AND THERE DID NOT APPEAR TO BE ANY HOLES OR TEARS. THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782606 ↗
• InjuryNov 24, 2025Mechanical Problem; Nonstandard Device; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE, AND THE PUMP STOPPED WORKING. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED, EXCEPT FOR THE RESERVOIR, WHICH COULD NOT BE EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630479 ↗
• InjuryOct 30, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Collapse; Fluid/Blood Leak; Inflation Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. THE CYLINDERS ARE NOT FILLING, AND THE PUMP IS PERSISTENTLY COLLAPSING. AS A RESULT, THE DEVICE WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425346 ↗
• InjuryOct 20, 2025Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY GETTING THE IMPLANT TO INFLATE AND COULD HEAR A SQUISHING SOUND IN THE PUMP. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THERE WAS A LEAK AND AIR BUBBLE IN THE DEVICE. A HOLE IN THE RIGHT CYLINDER WAS ALSO DISCOVERED, PRESUMABLY FROM THE PREVIOUS SURGERY AND A NEEDLE. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343329 ↗
• InjurySep 18, 2025Collapse; Mechanical Problem; Nonstandard Device; Collapse; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING PUMP. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086136 ↗
• InjuryAug 28, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE INABILITY TO INFLATE HIS INFLATABLE PENILE PROSTHESIS IPP DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH TIME THE PHYSICIAN CONFIRMED THAT BOTH CYLINDERS WERE SHREDDED AND HAD TISSUE INGROWTH. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Adhesion(s)

  MAUDE report 22919541 ↗
• InjuryAug 1, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) COULD NO LONGER BE INFLATED DUE TO FLUID LOSS IN THE SYSTEM. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687013 ↗
• InjuryJul 22, 2025Migration; Migration

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED, MAKING IT DIFFICULT FOR THE PATIENT TO ACCESS AND RESULTING IN DISSATISFACTION. THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565625 ↗
• InjuryJul 3, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WERE HOLES IN INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS, AND THE DEVICE WAS NO LONGER INFLATING. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM EXCEPT RESERVOIR. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399172 ↗
• InjuryJun 17, 2025Collapse; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Nonstandard Device; Failure to Deflate; Collapse; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Nonstandard Device; Failure to Deflate

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) HAS NEVER FUNCTIONED SINCE IMPLANTATION. THE PATIENT REPORTED BEING UNABLE TO INFLATE THE DEVICE AT ANY TIME, AND THE PHYSICIAN CONFIRMED THAT THE PUMP WAS NOT OPERATING AS EXPECTED. THE PUMP COULD NOT BE SQUEEZED, AND NO FLUID MOVED INTO THE CYLINDERS. THE DEVICE REMAINS IMPLANTED, AND A REVISION PROCEDURE IS SCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237828 ↗