AMS 700 CX MS Pump 72404236Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00878953003498), received between Nov 20, 2018 and Mar 24, 2026 — classified as 82 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (25 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 90 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) HAD BEEN IMPLANTED WITH UNDERSIZED CYLINDERS, RESULTING IN GLANS DROOPING AND DIFFICULTY WITH PENETRATION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE IPP WAS REMOVED AND REPLACED. THE ORIGINAL 15 CM CYLINDERS WERE EXCHANGED FOR NEW 18 CM CYLINDERS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24677365 ↗
• InjuryMar 11, 2026Nonstandard Device; Migration

  IT WAS REPORTED THAT THE CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD HERNIATED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS AND PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24576155 ↗
• InjuryMar 2, 2026Inflation Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483776 ↗
• InjuryDec 22, 2025Degraded; Nonstandard Device; Degraded; Nonstandard Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873075 ↗
• InjuryDec 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT 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 23750900 ↗
• InjuryDec 1, 2025Collapse; Inflation Problem; Material Puncture/Hole; Air/Gas in Device; Collapse; Inflation Problem; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED INFLATION ISSUES FOLLOWING A FALL, RESULTING IN RUPTURE OF THE RIGHT CYLINDER. DURING SURGERY, AIR WAS OBSERVED WITHIN THE DEVICE AND THE PUMP BULB REMAINED FLAT. THE IPP WAS REPLACED. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681828 ↗
• InjuryNov 17, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575575 ↗
• InjuryJun 26, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS PRESENTED WITH A DEVICE THAT WAS UNABLE TO INFLATE A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS WITHIN THE SYSTEM. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342159 ↗
• InjuryApr 9, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810633 ↗
• InjuryMar 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INFLATE HIS INFLATABLE PENILE PROSTHESIS (IPP) BECAUSE THE PUMP WAS VERY HARD TO SQUEEZE. THE PHYSICIAN WAS ABLE TO INFLATE AND DEFLATE THE DEVICE WHILE THE PATIENT WAS SEDATED; HOWEVER, THE IPP WAS REMOVED AND REPLACED, AND THE PHYSICIAN WILL INSTRUCT THE PATIENT TO USE IT REGULARLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662525 ↗
• InjuryFeb 20, 2025Adverse 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 AN INFECTION IN THE ENTIRE SHAFT AND SCROTUM. THE PATIENT HAD A SKIN BREAK AND DISTAL EROSION IN THE GLANS OF PENIS. PURULENT DRAINAGE WAS IDENTIFIED. THE EROSION WAS ASSOCIATED WITH THE TIP OF CYLINDER. THE IPP WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 21428935 ↗
• InjuryJan 21, 2025Migration; Migration

  IT WAS REPORTED THAT THE LEFT CYLINDER OF THIS INFLATABLE PENILE PROSTHESIS (IPP) MIGRATED OUT OF THE CORPORA AND INTO THE ABDOMEN. THE PHYSICIAN NOTED THAT THE PATIENT HAD NARROW CORPORAS. THE CYLINDER WAS EXPLANTED, AND THE TUBING WAS PLUGGED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 21198959 ↗
• InjuryDec 3, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT AND PHYSICIAN SUSPECTED THESE INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS WERE UNDERSIZED DURING THE INITIAL IMPLANT PROCEDURE, AS HE COULD PALPATE THE DISTAL TIPS OF THE CYLINDERS WITHIN THE PATIENT'S PENIS, AND THEY DID NOT EXTEND TO THE GLANS. A REVISION SURGERY WAS PERFORMED TO REMOVE CYLINDERS AND PUMP, REMEASURE, AND IMPLANT NEW COMPONENTS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833092 ↗
• InjuryOct 30, 2024Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO A TOTAL FLUID LOSS FROM THE SYSTEM. THE FLUID LOSS WAS IDENTIFIED BECAUSE THE DEVICE DID NOT INFLATE. THE LOCATION, SOURCE AND CAUSE OF THE FLUID LOSS WERE NOT IDENTIFIED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571524 ↗
• InjuryOct 1, 2024Deflation Problem; Adverse Event Without Identified Device or Use Problem; Deflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED DEFLATION ISSUES; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE ALL THE COMPONENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344247 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING CONCERNS WITH HIS INFLATABLE PENILE PROSTHESIS AS HE IS UNABLE TO ACHIEVE CLIMAX DURING INTERCOURSE AND FEELS NUMBNESS IN THE TIP OF HIS PENIS. BOSTON SCIENTIFIC PATIENT SERVICES SPECIALIST TOLD HIM THAT THIS COULD BE DUE TO EARLY HEALING STAGES AND IT MAY SUBSIDE, BUT ENCOURAGED HIM TO CONSULT WITH HIS DOCTOR OR A SEX THERAPIST FOR COUNSELING ON CLIMAX.

  Patient problems: Numbness; Sexual Dysfunction

  MAUDE report 20304281 ↗
• InjuryJul 3, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO A FLUID LOSS. IT WAS ALSO REPORTED THAT THE DEVICE COULD NOT MAINTAIN AN ERECTION AND THE PUMP REMAINS STUCK. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665316 ↗
• InjuryJun 18, 2024Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT PERFORMING AS EXPECTED DUE TO FLUID LOSS. THE PATIENT UNDERWENT SURGERY AND BOTH CYLINDERS WERE BROKEN IN BOTH SIDES, THE RESERVOIR WAS EMPTY. THE DEVICE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563482 ↗
• InjuryJun 6, 2024Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS REMOVED AND REPLACED DUE TO A TOTAL LOSS OF FLUID. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477465 ↗
• InjuryJun 3, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS WAS POSITIONED TOO HIGH. THE PUMP WAS EXPLANTED AND REPLACED DURING A CONCURRENT SURGERY RELATED TO THE CONCOMITANT ARTIFICIAL URINARY SPHINCTER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454597 ↗
• InjuryMay 22, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION DUE TO MIGRATION OF THE DEVICE COMPONENTS. IT WAS NOTED THAT THE SUTURES DISINTEGRATED, AND THE IMPLANT MOVED. THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373895 ↗
• MalfunctionMay 7, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) IS UNABLE TO USE THE PUMP. DURING THE ORIGINAL IMPLANT, THE CYLINDERS AND PUMP WERE WORKING PROPERLY. POST PROCEDURE, THE MEDICAL SPECIALIST MADE MULTIPLE ATTEMPTS TO ACTIVATE THE PUMP AND WAS UNSUCCESSFUL. A REVISION PROCEDURE WAS SCHEDULED TO CHANGE OUT THE IPP. THERE HAS BEEN NO SURGICAL INTERVENTION AT THIS TIME, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260796 ↗
• InjuryApr 22, 2024Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED DUE TO A TOTAL LOSS OF FLUID. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152759 ↗
• InjuryMar 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 AN INFECTION WHICH CAUSED THE PENIS TO BE SWOLLEN. A REVISION SURGERY WAS PERFORMED TO EXPLANT AND REPLACE THE IPP WITH A MALLEABLE DEVICE. NO DEVICE ISSUES NOR ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 18945438 ↗
• InjuryMar 20, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT FUNCTIONING DUE TO FLUID LOSS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940418 ↗