AMS 700 CX MS Pump 72404239Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00878953003528), received between Oct 12, 2018 and Jun 29, 2026 — classified as 42 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (16 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Mechanical Problem; Unintended Deflation

  It was reported that the pump of this Inflatable Penile Prosthesis (IPP) was not working properly. The patient was unable to achieve maximum rigidity, as the valve would release prematurely, resulting in deflation of the implant. As a result, the pump was explanted and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661241 ↗
• InjuryJan 14, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING CORRECTLY. THE DEVICE WAS REPORTED TO BE EXPERIENCING FLUID LOSS, AND THE OUTER SILICONE SHEATH OF BOTH CYLINDERS WAS DESCRIBED AS STRIPPED OR DEGLOVED. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED, WHILE THE RESERVOIR WAS RETAINED AND REFILLED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068103 ↗
• InjuryJul 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. 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 22548856 ↗
• InjuryJul 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION OF THE RIGHT CYLINDER, RENDERING THE DEVICE NONFUNCTIONAL. THE IPP WAS SUBSEQUENTLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 22471992 ↗
• InjuryApr 9, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING SINCE (B)(6) 2024. THE PATIENT STATED THAT THE DOCTOR CONFIRMED THAT IT WAS A FLUID LEAK, AND A REPLACEMENT WOULD BE NEEDED. THE PATIENT STATED THAT HE EXPERIENCED PAIN. NO REVISION SURGERY HAS BEEN INFORMED, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 21805440 ↗
• InjuryMar 26, 2025Degraded; Inflation Problem; Mechanical Problem; Degraded; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A MECHANICAL FAILURE OF HIS INFLATABLE PENILE PROSTHESIS (IPP). TOMOGRAPHY REVEALED AN ANEURYSM IN THE CYLINDERS AT THE BASE OF THE PENILE SHAFT, AND THE PHYSICIAN SUSPECTS EROSION. ADDITIONALLY, THE DEVICE WAS NOT INFLATING PROPERLY, AND THE PROSTHESIS PRESENTS AXIAL INSTABILITY. A REVISION SURGERY HAS BEEN REQUESTED; NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Erosion

  MAUDE report 21704198 ↗
• InjuryJan 2, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING DUE FLUID LOSS. UPON REVISION, A HOLE IN THE CYLINDER WAS DISCOVERED. IMPLANT EXPERIENCED WEAR AND TEAR. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063350 ↗
• MalfunctionNov 21, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS IS HAVING ISSUES WITH A CYLINDER ANEURYSM. THE PATIENT FOLLOWED UP WITH THE PHYSICIAN AND PHYSICIAN STATED THE NEED FOR ADDITIONAL SURGERY. THE PATIENT SERVICE SPECIALIST SUGGESTED THE PATIENT TO CONSULT THE PHYSICIAN FOR MOST OF HIS INQUIRIES AND TO MANAGE THE CYLINDER ANEURYSM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748200 ↗
• InjuryOct 28, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A REVISION DUE TO A BULGE IN THE DISTAL CORPORAL BODY. THE IPP WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20549929 ↗
• InjuryOct 17, 2024Nonstandard Device; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Migration; Nonstandard Device; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION IN THE RIGHT CORPOROTOMY, AND MIGRATION OF THE RIGHT CYLINDER FROM THE RIGHT CORPOROTOMY TO THE SCROTUM, AS HE STARTED USING THE DEVICE PRIOR THE RECOVERY PERIOD. A REVISION SURGERY WAS PERFORMED, AND IT WAS NOTED THAT, IN ADDITION, THE RIGHT CYLINDER WAS TOO LARGE FOR PATIENT'S ANATOMY; THEREFORE, THE COMPONENT WAS REMOVED AND REPLACED WITH A SMALLER ONE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Erosion

  MAUDE report 20471842 ↗
• InjuryOct 11, 2024Inflation Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY DUE TO INFLATION ISSUES. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THE CYLINDER WAS SHREDDED AND STUCK IN THE CORPORA. CYLINDERS AND PUMP WERE REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS DRAINED AND RETAINED, AND A NEW ONE WAS ADDED TO THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Adhesion(s)

  MAUDE report 20427208 ↗
• MalfunctionSep 25, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANT OF AN INFLATABLE PENILE PROSTHESIS (IPP), AFTER CLOSING THE PATIENT'S CORPORA, THE LEFT CYLINDER WOULD NOT DEFLATE AT A NORMAL RATE. TROUBLESHOOTING MEASURES WERE PERFORMED BUT WERE NOT SUCCESSFUL. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301509 ↗
• InjuryAug 20, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFECTION. IT WAS ALSO OBSERVED THAT THE RESERVOIR WAS ORIGINALLY IMPLANTED ON THE RIGHT SIDE AND MIGRATED TO THE SCROTUM AREA. THE RESERVOIR WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 20007541 ↗
• InjuryJul 10, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY DEFLATING THE DEVICE AND FELT A LUMP IN THEIR PENIS THAT CAUSES PAIN THREE WEEKS POST AFTER IMPLANT. THE PATIENT WILL FOLLOW UP WITH THEIR PHYSICIAN. THERE HAS BEEN NO SURGICAL INTERVENTION AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 19714766 ↗
• InjuryJun 6, 2024Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING AS EXPECTED DUE TO FLUID LOSS. IT WAS NOTED THERE WAS A HOLE IN THE CYLINDER. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476889 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND IMPLANT A NEW MALLEABLE PENILE PROSTHESIS. THERE WERE NO DEVICE ISSUES AND NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18743336 ↗
• InjuryFeb 7, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE LEFT CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS WAS NOT INFLATING; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664982 ↗
• InjuryDec 8, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED A LEFT PROXIMAL CYLINDER TEAR WITH RESULTANT FLUID LOSS. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293483 ↗
• InjuryNov 29, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS REVISION SURGERY DUE TO A FLUID LOSS. UPON EXPLANT, A TEAR IN THE PROXIMAL RIGHT CYLINDER WAS NOTED; THEREFORE, CYLINDERS AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234667 ↗
• InjurySep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED DUE TO FLUID LOSS. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740986 ↗
• InjuryAug 18, 2023Collapse; Deflation Problem; Mechanical Problem; Migration; Collapse; Deflation Problem; Mechanical Problem; Migration

  IT WAS REPORTED THAT WITHIN THE FIRST FEW DAYS POST-IMPLANT OF THIS INFLATABLE PENILE PROSTHESIS, THE PATIENT EXPERIENCED INTENSE PAIN AND TENDERNESS IN HIS STOMACH AND SCROTUM. ADDITIONALLY, THE PUMP OF THE IPP DID NOT INFLATE PROPERLY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM BECAUSE HE WAS UNABLE TO DEFLATE HIS PROSTHESES FOR TWO DAYS FOLLOWING INTERCOURSE. AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS DEFLATED. A PHYSICAL EXAM CONFIRMED PAIN, DISCOMFORT AND SIGNIFICANT SWELLING IN THE AREA OF PUMP IMPLANT. THE PATIENT WAS SEEN BY THE PHYSICIAN FOR A FOLLOW-UP APPOINTMENT AS THE PATIENT WAS UNABLE TO FULLY PUMP THE IMPLANT; THIS RESULTED IN PAIN AND NON-FUNCTIONAL DEVICE. A PHYSICAL EXAMINATION BY THE PHYSICIAN CONFIRMED THE COLLAPSED PUMP WAS CONSISTENT WITH A MALFUNCTIONING PUMP OR LEAK. AFTER ALLOWING THE SWELLING TO SUBSIDE, THE PATIENT WAS SEEN BY THE PHYSICIAN AGAIN. THE PHYSICIAN NOTED THAT THE PUMP HAD SHIFTED, AND THE DEFLATION BUTTON WAS NOW ON THE LEFT SIDE. THE PHYSICIAN INSTRUCTED THE PATIENT ON THE USE OF THE PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 17575100 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO INFECTION. A NEW MALLEABLE PENILE PROSTHESIS WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17376690 ↗
• InjuryMay 30, 2023Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY BECAUSE THE RIGHT CYLINDER PRESENTED AN ANEURISM. ALL COMPONENTS WERE REMOVED AND REPLACED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020119 ↗
• InjuryMay 2, 2023Inadequacy of Device Shape and/or Size; Defective Device; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS TOO LARGE AND BUCKLING. IT WAS CREATING A SIDEWAYS CURVATURE. IT WAS DECIDED THAT THE SIZE WAS TOO LARGE UPON IMPLANT. THE PHYSICIAN PERFORMED A SURGERY TO REDUCE THE SIZE OF THE DEVICE; THE REAR TIPS WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852777 ↗
• InjuryApr 19, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE IMPLANTED IN (B)(6) 2022. HE REPORTED HAVING DIFFICULTY SQUEEZING THE PUMP WHICH RESULTED IN ONLY BEING ABLE TO INFLATE THE DEVICE HALFWAY. WHEN THE PATIENT SAW HIS PHYSICIAN, THE PHYSICIAN WAS UNABLE TO INFLATE THE DEVICE FULLY BECAUSE THE PATIENT EXPERIENCED DISCOMFORT. THE IPP DEVICE WAS EXPLANTED, AND A NEW TACTRA PENILE PROSTHESIS DEVICE WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 16769723 ↗