AMS 700 CX MS Pump 72404280Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878953003832), received between Aug 5, 2019 and Aug 21, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO THE DEVICE DOES NOT INFLATE OR DEFLATE. THE IPP IS CURRENTLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014389 ↗
• InjuryApr 26, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND REDNESS AT THE INCISION SITE AND WAS NOT ABLE TO INFLATE OR DEFLATE THE INFLATABLE PENILE PROSTHESIS. A CYSTOSCOPY FOUND EXTRUSION OF THE DEVICE THROUGH THE URETHRA. THE PATIENT WAS EXPECTED TO UNDERGO A REVISION SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Inflammation; Pain

  MAUDE report 14214675 ↗
• MalfunctionNov 9, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PUMP OF THIS INFLATABLE PENILE PROTHESIS WAS TESTED BY THE PHYSICIAN AND FOUND TO LOCK DURING ACTIVATION AND DEACTIVATION. A REVISION PROCEDURE WAS SCHEDULED AS THE DEVICE IS NOT USABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783984 ↗
• MalfunctionOct 18, 2021Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INOPERABILITY OF THE INFLATABLE PENILE PROSTHESIS (IPP). THE PHYSICIAN ASSESSED THE DEVICE AND THE CYLINDERS DID NOT FILL AFTER COMPRESSING THE PUMP. THE DEVICE WAS EVALUATED THROUGH AN ULTRASOUND AN A FULL RESERVOIR WAS OBSERVED. THEREFORE, THE PHYSICIAN DETERMINED THAT A MECHANICAL FAILURE IS THE MOST PROBABLE CAUSE OF THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648936 ↗
• MalfunctionSep 23, 2019Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem; Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP WERE IN A PACKAGE WITH INHIBIZONE STICKER ON THE OUTSIDE. THIS PRODUCT WAS NON-INHIBIZONE INFLATABLE PENILE PROSTHESIS CYLINDERS AND PUMP. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9107130 ↗
• InjuryAug 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DUE TO DIFFICULTY WITH PUMPING THE PATIENT WILL HAVE HIS INFLATABLE PENILE PROSTHESIS (IPP) REMOVED AND REPLACED. IT WAS EXPLAINED THAT DURING EVALUATION THE PHYSICIAN NOTED THE PUMP DOES NOT REFILL AFTER PUMPING. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8861063 ↗