AMS 700 CX MS Pump 72404282Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00878953003856), received between Oct 16, 2018 and Aug 11, 2026 — classified as 41 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (23 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this patient with an Inflatable Penile Prosthesis (IPP) experienced continuous fluid discharge from the scrotal wound at the junction of the penis and the scrotum, and infection at the scrotum. The wound could not heal completely. A surgical procedure was performed during which the entire device was explanted. The patient was stable following the procedure, and no additional information was provided.

  Patient problems: Fluid Discharge; Impaired Healing; Inflammation; Unspecified Infection

  MAUDE report 50202743 ↗
• InjuryApr 8, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN AND DIFFICULTY WHEN ATTEMPTING TO OPERATE A STIFF PUMP. A MAGNETIC RESONANCE IMAGING (MRI) STUDY WAS PERFORMED, AND NO DEVICE RELATED ISSUES WERE IDENTIFIED. THE PATIENT SUBSEQUENTLY DISCONTINUED USE OF THE IPP. THE DEVICE REMAINS IMPLANTED AT THIS TIME, AND A REVISION WILL BE REQUIRED.

  Patient problems: Pain

  MAUDE report 24818951 ↗
• InjuryDec 12, 2025Degraded; Mechanical Problem; Nonstandard Device; Degraded; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT WAS NOT WORKING PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE CYLINDER HAD A BALLOONING, SO ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790150 ↗
• InjuryAug 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED LOW CYLINDER STRENGTH; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO ADD ADDITIONAL SALINE TO THE RESERVOIR. NO COMPONENTS WERE REMOVED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916808 ↗
• InjuryMay 28, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. THE PATIENT EXPERIENCED INDURATION AT THE ROOT OF THE PATIENT PENIS WAS PALPATED BY THE PHYSICIAN. THE CYLINDERS WERE EXPLANTED AND REPLACED. IT WAS NOTICED THAT THE DEVICE WAS DAMAGED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Deformity/ Disfigurement; Inflammation

  MAUDE report 22095541 ↗
• MalfunctionApr 2, 2025Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD FLUID LOSS. THE IPP WAS NOT INFLATING. IT WAS NOTICED THAT THE DEVICE DID NOT HAVE RIGIDITY. THE DEVICE IS STILL IMPLANTED, AND A SURGERY WILL BE PERFORMED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753907 ↗
• InjuryJan 14, 2025Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INFLATABLE PENILE PROSTHESIS (IPP), THE PUMP ADHERED TO THE SKIN AND THE CYLINDER COULD NOT BE FULLY INFLATED. UPON REVISION, IT WAS DETERMINED THAT THE PATIENT NEEDED TO HAVE THE IPP REMOVED AND REPLACED WITH A NEW ONE. DUE TO THE REPLACEMENT SURGERY, IT WAS NECESSARY TO PROLONG THE PATIENT'S HOSPITALIZATION TO PREVENT AN INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Adhesion(s)

  MAUDE report 21150050 ↗
• InjuryDec 30, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PUMP IS NOT WORKING PROPERLY; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE ALL THE COMPONENTS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037194 ↗
• InjuryNov 26, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY BECAUSE THE PATIENT COULD NOT INFLATE THE DEVICE. AFTER REVISION, IT WAS FOUND THAT THE PUMP WORKED AS EXPECTED AND THE IPP WAS INFLATING WITHOUT ISSUES. SCAR TISSUE CAUSED ISSUES WITH INFLATION FOR THE PATIENT. PHYSICIAN DECIDED TO REPLACE THE PUMP ONLY, AS IT WAS EXPOSED FROM SCROTAL CAPSULE BY WAY OF THE INCISION THE SURGEON MADE TO REVISE THE PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Scar Tissue

  MAUDE report 20777927 ↗
• InjuryApr 10, 2024Collapse; Deflation Problem; Inflation Problem; Defective Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Collapse; Deflation Problem; Inflation Problem; Defective Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT. AN ATTEMPT WAS MADE TO ACTIVATE THE DEVICE; HOWEVER, IT WAS FOUND THAT THE DEVICE DOES NOT INFLATE NOR DEFLATE BEING A BLOCKAGE IN THE TUBE BETWEEN THE RESERVOIR AND PUMP THE SUSPECTED CAUSE. IN ADDITION, THE PUMP WAS REPORTED TO STAY FLAT WHEN PRESSED. A FORCED DEFLATION MANEUVER WAS PERFORMED. THE DEVICE REMAINS IMPLANTED, AND A REVISION SURGERY HAS NOT BEEN SCHEDULED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 19084557 ↗
• InjuryMar 4, 2024Collapse; Defective Device; Collapse; Defective Device

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS WAS COLLAPSED, WHICH RESULTED IN AN INABILITY FOR THE COMPONENT TO TRANSFER FLUID TO THE CYLINDERS. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE ALL THE COMPONENTS. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827649 ↗
• InjuryFeb 9, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE INFLATABLE PENILE PROSTHESIS WAS REMOVED AND REPLACED DUE TO A CRACK IN THE RESERVOIR CONNECTING TUBE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675647 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXTRUDED FROM THE PENIS. PREVIOUSLY, THE PATIENT HAD EXPERIENCED SEVERE PELVIS TRAUMA WITH LARGE BONE DEFORMITY REQUIRING COMPLEX URETHROPLASTY. THE DEVICE REMAINS IMPLANTED, AND A REVISION SURGERY IS PLANNED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 18659390 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT SITE OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS ITCHY, SWOLLEN AND RED DUE TO AN INFECTION. THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Itching Sensation; Swelling/ Edema; Unspecified Infection

  MAUDE report 18232087 ↗
• InjuryNov 20, 2023Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN AND SCROTAL SENSITIVITY. THIS RESULTED IN HIS INABILITY TO INFLATE THE DEVICE. ADDITIONALLY, THE PUMP WAS REPORTED TO BE RIGID. AN ATTEMPT WAS MADE TO UNLOCK THE PUMP, BUT IT WAS UNSUCCESSFUL. A REVISION SURGERY HAS BEEN SCHEDULED TO REPLACE THE IPP WITH A MALLEABLE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 18173640 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFECTION, REDNESS, SWELLING AND PUS DISCHARGE IN THE SCROTUM. ONE WEEK LATER, A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE AND, POSTOPERATIVELY, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICATION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Purulent Discharge; Skin Inflammation/ Irritation; Swelling/ Edema; Unspecified Infection

  MAUDE report 18020595 ↗
• InjurySep 21, 2023Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN, DISCOMFORT AND SWELLING IN THE PROXIMAL PART OF THE PENIS. DUE TO THE SWELLING, IT IS DIFFICULT TO INFLATE THE DEVICE; THEREFORE, THE IPP IS NOT CYCLING PROPERLY. A REVISION SURGERY HAS BEEN SCHEDULED.

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 17788295 ↗
• InjuryJun 6, 2023Inflation Problem; Mechanical Problem; Defective Device; Inflation Problem; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING AND IT IS NO LONGER INFLATING. THE PHYSICIAN EVALUATED THE DEVICE AND IT WAS NOTICED THAT THE PUMP CANNOT BE PRESSED. IMAGING SHOWS FLUID IN THE RESERVOIR. THE PATIENT REPORTS LEFT SIDE PENIS, TESTICULAR AND PERINEAL PAIN. THE PATIENT CANNOT SLEEP IN THE LEFT LATERAL DECUBITUS POSITION DUE TO PAIN IN THE PUMP REGION AND HE EXPERIENCE PERINEAL PAIN WHEN SITTING DOWN. THE PHYSICIAN REQUESTS REPLACEMENT OF THE DEVICE, AS IT IS NO LONGER INFLATING.

  Patient problems: Pain

  MAUDE report 17070651 ↗
• InjuryJun 1, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS IMPLANTED, THE PATIENT WAS NOT ABLE TO FULLY INFLATE THE DEVICE IN ORDER TO ACHIEVE AN ERECTION. THE PHYSICIAN TRIED TO ADJUST THE DEVICE OUTSIDE THE PATIENT BUT WAS UNABLE TO INFLATE THE DEVICE. AFTER SURGICAL EXPLORATION AND STILL BEING UNABLE TO INFLATE THE DEVICE, THE PHYSICIAN EXPLANTED THE IPP DEVICE NINE DAYS AFTER IT WAS ORIGINALLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043998 ↗
• InjuryMar 23, 2023Collapse; Fluid/Blood Leak; Inflation Problem; Collapse; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP COLLAPSE AND DIFFICULTY IN COMPLETELY FILLING THE CYLINDERS. MAGNETIC RESONANCE IMAGING (MRI) REVEALED AN EMPTY RESERVOIR WITH SIGNS OF EXTRAVASATION AT THE CONNECTION LEVEL BETWEEN THE PUMP AND TUBING. THE IPP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607260 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, TWO WEEKS POST-IMPLANT OF THIS INFLATABLE PENILE PROSTHESIS, HYPEREMIA OF THE SURGICAL WOUND WAS OBSERVED WITH ASSOCIATED CLEAR SECRETION. THE PATIENT WAS TREATED WITH SEVERAL ANTIBIOTIC THERAPY SCHEMES AND FOLLOWED UP WITH AN INFECTION SPECIALIST. THE EXTERNAL APPEARANCE OF THE SURGICAL WOUND WORSENED, AND THE SECRETION THICKENED TO A PURULENT DISCHARGE. THE DEVICE WAS EXPLANTED DUE TO INFECTION WITH A CONCURRENT PROCEDURE PERFORMED TO RESCUE THE TISSUE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fluid Discharge; Inflammation; Purulent Discharge; Unspecified Infection

  MAUDE report 16305163 ↗
• MalfunctionJan 10, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) DOES NOT INFLATE EVEN WHEN THE PUMP IS USED CORRECTLY. A REVISION SURGERY WILL BE PERFORMED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134037 ↗
• MalfunctionDec 15, 2022Fluid/Blood Leak; Mechanical Problem; Air/Gas in Device; Fluid/Blood Leak; Mechanical Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MECHANICAL ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP). AN ULTRASOUND WAS PERFORMED, IDENTIFYING FLUID LOSS AND AIR IN THE COMPONENTS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987366 ↗
• MalfunctionDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS RETURNED WITH NO PRODUCT ALLEGATION. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986148 ↗
• InjuryDec 14, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS PUMP REPLACED AS IT WAS RIDING HIGH IN THE SCROTUM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983685 ↗