AMS 700 CX MS Pump 72404234Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00878953003474), received between May 7, 2019 and May 9, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 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. UPON EXPLANT, A BREAK IN THE TUBING NEAR THE CONNECTION POINT TO THE RESERVOIR AND TEARING IN THE LEFT CYLINDER WAS IDENTIFIED, CAUSING A FLUID LOSS. ALL THE COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994482 ↗
• InjuryNov 14, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A SIGNIFICANT CURVE IN THE PENIS, CLOSE TO NINETY DEGREES, BETWEEN THE MID-SHAFT AND THE BASE OF PENIS THAT WAS NOT PRESENT DURING THE ORIGINAL PROCEDURE. THE PHYSICIAN HAD THE PATIENT LEAVE THE IMPLANT PARTIALLY INFLATED FOR HEMOSTASIS, UNTIL TWO WEEK FOLLOW UP APPOINTMENT. DURING THIS TIME, THE IMPLANT WAS INFLATED IT AND REMAINED BENT. FOUR WEEKS LATER, AT ACTIVATION, A SIGNIFICANT CURVE WAS NOTED UPON INFLATION. SURGICAL INTERVENTION WAS PERFORMED, AND THE REAR TIP EXTENDERS (RTES) WERE EXPLANTED DUE TO POSSIBLE OVERSIZING OF ORIGINAL CYLINDERS AFTER REMEASURING TOTAL CORPORAL LENGTH. THE ORIGINAL CYLINDERS WERE USED AND THE SURGEON PERFORMED PENILE MODELING TO CORRECT THE RESIDUAL CURVE. THE ORIGINAL RESERVOIR WAS LEFT IN PLACE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20682824 ↗
• InjurySep 4, 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 REVISED DUE TO FLUID LOSS. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137875 ↗
• InjuryJun 4, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING DUE TO FLUID LOSS. 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 19459062 ↗
• InjuryMay 9, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION DUE TO FLUID LOSS. IT WAS NOTED THAT THE CYLINDER HAD SPLIT CAUSING FLUID LOSS. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279600 ↗
• InjuryApr 2, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH DISCOMFORT AT THE DISTAL TIP OF THE LEFT CYLINDER. SURGICAL INTERVENTION WAS PERFORMED TO REPOSITION THE DISTAL TIP ON THAT SIDE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 19020244 ↗
• InjuryJun 8, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT DUE TO MECHANICAL ISSUES. THE CAUSE OF THE ANOMALY WAS NOT IDENTIFIED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087587 ↗
• InjuryOct 28, 2022Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO BOTH CYLINDERS RUPTURED. ALL COMPONENTS WERE REMOVED AND REPLACED WITH NEW ONES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692471 ↗
• InjuryFeb 15, 2022Fluid/Blood Leak; Material Puncture/Hole; Inadequacy of Device Shape and/or Size; Fluid/Blood Leak; Material Puncture/Hole; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION AS THE CYLINDER NO LONGER INFLATED AND IMPENDING DISTAL PENILE EROSION WAS IDENTIFIED. DURING SURGERY, BOTH CYLINDERS WERE FOUND TO BE TORN AND THERE WAS NO FLUID IN THE SYSTEM. THE PHYSICIAN BELIEVES THE CYLINDERS WERE OVERSIZED AND EXCESS WEAR MAY HAVE BEEN THE REASON FOR THE MATERIAL TEAR. THE EXISTING CYLINDERS AND PUMP WERE EXPLANTED AND THE NEW COMPONENTS WERE PLUGGED IN TO THE EXISTING RESERVOIR. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT IS EXPECTED TO RECOVER.

  Patient problems: Erosion

  MAUDE report 13539107 ↗
• InjuryJan 31, 2022Degraded; Inadequacy of Device Shape and/or Size; Degraded; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT FOLLOWING IMPLANT, THE DEVICE WAS INITIALLY FULLY FUNCTIONAL; HOWEVER, WITH ONGOING INFLATION, SOME BUCKLING OF THE CYLINDERS OCCURRED, INDICATING THAT OVER-SIZING WAS LIKELY. A PROCEDURE TO DOWNSIZE THE REAR TIP EXTENDERS (RTE) ATTACHED TO THE DEVICE WAS PERFORMED. DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE DEVICE WAS TOO LARGE AND THIS CAUSED A DEFORMITY OF THE INFLATED CYLINDERS. DURING THAT PROCEDURE THE RTES WERE COMPLETELY REMOVED. IT IS BELIEVED THAT, DURING THE CLOSING OF THE SURGICAL WOUND, THE SURGEON LIKELY PASSED A SUTURE NEEDLE THOUGH THE CYLINDER WALL, AS THE DEVICE SUDDENLY AUTOMATICALLY DEFLATED AND WOULD NOT REMAIN INFLATED. SUBSEQUENTLY, THE CYLINDERS AND PUMP WERE ALSO REPLACED. ONLY THE ORIGINAL RESERVOIR REMAINED IN SITU, AND THIS COMPONENT WAS VOLUME TESTED, EMPTIED, AND THEN REFILLED WITH NEW SALINE. AS A 24CM DEVICE WAS NOT AVAILABLE DURING THE REVISION SURGERY, A 21CM CX DEVICE WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13406365 ↗
• InjuryMar 22, 2021Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Noise, Audible; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MECHANICAL ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP) AFTER HEARING A "POP" DURING ITS USE. TROUBLESHOOTING STEPS WERE TAKEN TO TRY TO INFLATE THE DEVICE TO NO AVAIL. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING CYLINDERS WERE REMOVED AND REPLACED WITH NEW COMPONENTS. DURING THE PROCEDURE, FLUID LOSS WAS NOTED AT THE BASE OF THE CYLINDERS DUE TO A HOLE. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541871 ↗
• InjuryMar 22, 2021Degraded; Degraded

  IT WAS REPORTED THAT WHILE THE PATIENT WAS HAVING INTERCOURSE WITH HER PARTNER APPROXIMATELY 2 WEEKS AGO, HE FELT A PAINFUL SENSATION AT THE BASE OF HIS PENIS AND NOW NOTES A BULGE AT THE RIGHT SIDE THAT HAS NOT RESOLVED. PATIENT SERVICES SPECIALIST RECOMMENDED HIM TO SEE HIS DOCTOR FOR ASSESSMENT. THE PATIENT WILL FOLLOW-UP AFTER THE APPOINTMENT WITH AN UPDATE.

  Patient problems: Pain

  MAUDE report 11541719 ↗
• InjuryJan 13, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SURGICAL PROCEDURE TO EXPLANT AN INFLATABLE PENILE PROSTHESIS(IPP) DUE TO THE IMPLANT BEING OVERSIZED. THE PATIENT IS EXPECTED TO FULLY RECOVER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11160753 ↗
• InjuryDec 16, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO UNSPECIFIED REASONS WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER, PUMP, AND RESERVOIR WAS EXPLANTED AND A NEW IPP CYLINDER, PUMP, AND RESERVOIR WAS IMPLANTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT PRESENTED TO THE PHYSICIAN THAT THE PUMP WAS RIDING HIGH AND THE PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9473377 ↗
• InjuryNov 27, 2019Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT PATIENT CONTACTED THE PHYSICIAN COMPLAINING OF A MALFUNCTIONING INFLATABLE PENILE PROSTHESIS (IPP) DEVICE (REPORTEDLY NOTICED ABOUT 3 MONTHS AGO AROUND (B)(6) 2019). UPON EXAMINATION AND MRI IT WAS OBSERVED THAT ONE CYLINDER HAD ANEURYSM. PHYSICIAN EXPLANTED THE CYLINDERS AND PUMP BUT HAD TO LEAVE THE RESERVOIR IN PLACE. HE ALSO VISUALLY CONFIRMED THE ANEURYSM IN THE AFFECTED CYLINDER PATIENT WAS GRAFTED AND REIMPLANTED WITH A COLOPLAST TITAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9382712 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFALLIBLE PENILE PROSTHESIS (IPP) DUE TO THE RESERVOIR HERNIATED OUT F SPACE AND THE PUMP WAS HIGH RIDING IN THE PATIENT'S SCROTUM. THE RESERVOIR AND PUMP WERE REMOVED AND REPLACED. THE PATIENT HAD A GOOD OUTCOME. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS RELEVANT INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION RECEIVED. THE PATIENT PRESENTED A BULGE IN THE ABDOMEN DUE TO THE HERNIATED RESERVOIR AND HAD DIFFICULTY CYCLING HIS DEVICE BECAUSE OF HIS HIGH RIDING PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9218348 ↗
• InjuryMay 7, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT HAD THREE PENILE IMPLANTS AND THAT THE LAST ONE ONLY LASTED TWO YEARS. HE CLAIMS HE WAS TOLD THE DEVICE WOULD LAST TEN YEARS AND WANTED TO KNOW WHAT THE LIFE SPAN OF THE DEVICE WAS. HE WAS INFORMED THAT EACH DEVICE HAD A DIFFERENT LIFE SPAN FOR DIFFERENT PATIENTS AND THAT IT WAS A MECHANICAL DEVICE SO THERE IS NOT A FIRM TIME FRAME ON FAILURE RATES. WE DID GO OVER THE WARRANTY POLICY. HE ASKED WHAT BOSTON SCIENTIFIC IS GOING TO GIVE HIM FOR HIS PAIN AND SUFFERING. I LET HIM KNOW THAT THE WARRANTY ONLY COVERED THE COST OF THE DEVICE AT THE TIME IT WAS PLACED IF THE CONDITIONS OF THE WARRANTY WERE MET. AGAIN, HE ASKED FOR COMPENSATION FOR HIS PAIN AND SUFFERING. I LET HIM KNOW THAT I DID NOT HAVE ANY AUTHORITY OVER FINANCIAL DECISIONS. HE ASKED TO SPEAK TO THE LEGAL DEPARTMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587419 ↗