AMS 700 CXR MS Pump 72404267Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00878953003757), received between May 20, 2019 and Jun 30, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (4 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.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION IN THE RIGHT CYLINDER THROUGH THE GLANDS, WITH SOME CENTIMETERS OF THE CYLINDER VISIBLE EXTERNALLY. AS A RESULT, THE RIGHT CYLINDER WAS EXPLANTED, AND THE TUBING WAS DEACTIVATED TO ALLOW THE LEFT CYLINDER TO CONTINUE FUNCTIONING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 25673519 ↗
• InjuryJan 20, 2026Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE HAD AN EXPLANT SURGERY AND DURING EXPLANT SURGERY, THERE WAS A PINPOINT EXPOSURE OF THE PUMP IN THE RIGHT SCROTUM, AND AN EXPOSED CYLINDER AT THE URETHRAL MEATUS INDICATIVE OF EROSION. A TRANSVERSE INCISION WAS MADE AT THE PENOSCROTAL JUNCTION, AND THIS WAS THE SITE OF THE PATIENT'S PRIOR INCISION AND SCAR TISSUE WAS SEEN. A CATHETER COULD NOT BE PLACED DURING THIS POINT OF THE PROCEDURE DUE TO THE ERODED CYLINDER AT THE MEATUS, SO THE PHYSICIAN DISSECTED DOWN TOWARDS THE CORPORA. AT THE TIME WHEN THE PHYSICIAN REMOVED THE CYLINDER COMPONENTS, THEY PASSED A FLEXIBLE CYSTOSCOPE INTO THE MEATUS AND INTO THE LEFT CORPORA WHICH THEY NOTED DISTAL SCARRING/EROSION. ALL IPP IMPLANT DEVICE COMPONENTS WERE REMOVED DURING THE EXPLANT SURGERY, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Scar Tissue

  MAUDE report 24127213 ↗
• MalfunctionOct 22, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT SURGERY, THE MEDICAL STAFF COMPRESSED THE PUMP BULB SEVERAL TIMES TO INFLATE THE CYLINDERS, AND WHEN THEY PUSHED AND HELD THE DEFLATE BUTTON, NOTHING HAPPENED. AFTER SEVERAL ATTEMPTS, THEY HAD TO SQUEEZE THE SIDES OF THE PUMP BLOCK; THIS WORKS, BUT WHEN CYCLING, THE ORIGINAL DEFLATE BUTTON HAS THE SAME ISSUE. THE PHYSICIAN CYCLES THE IMPLANT AGAIN AND RAN INTO THE SAME ISSUE. ALSO, IT WAS NOTICED THAT THE PUMP FILLED MUCH SLOWER THAN IT SHOULD. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE INSTEAD, WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502078 ↗
• InjuryApr 29, 2024Inflation Problem; Mechanical Problem; Defective Device; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Mechanical Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY, AS IT WAS BLOCKED AND WAS NOT FULLY INFLATING THE CYLINDERS. ONE WEEK LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202848 ↗
• InjuryMar 18, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THAT WAS NO LONGER INFLATING. THE IPP WAS FOUND TO HAVE A LEAK AND WAS REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927385 ↗
• InjuryDec 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, APPROXIMATELY SIX MONTHS POST-IMPLANT OF THIS INFLATABLE PENILE PROSTHESIS (IPP), THE PATIENT PRESENTED WITH AN INFECTION OF THE SCROTUM AND CORPORA. THE DEVICE WAS EXPLANTED AND A WASHOUT OF THE AREA WAS PERFORMED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18263182 ↗
• InjurySep 27, 2023Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE INFLATABLE PENILE PROSTHESIS (IPP)DUE TO THE IMPLANT NOT INFLATING PROPERLY. THE PHYSICIAN BELIEVED THAT THERE WAS MATERIAL DAMAGE AND IDENTIFIED A FLUID LEAK FROM THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827258 ↗
• InjuryJan 13, 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. THE INFECTION BEGAN IN SEPTEMBER WAS TREATED APPROPRIATELY AT THAT POINT IN TIME. THE INFECTION DID NOT IMPROVE WITH TREATMENT, SO A TOTAL EXPLANT WAS PERFORMED. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 16162622 ↗
• InjuryNov 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD AN IN-CLINIC EVALUATION AS THE DEVICE WAS NO LONGER FUNCTIONAL. A MECHANICAL ISSUE WAS CONFIRMED AFTER PALPATION AND VISUAL INSPECTION OF THE DEVICE; THEREFORE, IT WAS DECIDED TO PERFORM A REVISION. THE ENTIRE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15891124 ↗
• InjuryNov 7, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY IN WHICH THE PUMP AND CYLINDERS WERE REMOVED AND REPLACED BECAUSE THE DEVICE WAS PIERCED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749771 ↗
• InjuryFeb 10, 2022Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Collapse; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFLATABLE PENILE PROSTHESIS (IPP) INFLATION ISSUES. THE DOCTOR TRIED TO INFLATE WITHOUT SUCCESS DUE TO THE PUMP WAS DIMPLED AND WOULD NOT REFILL. A SURGERY WAS PERFORMED AND A BRAKE AT THE TUBING WAS IDENTIFIED; THEREFORE, THERE WAS NO FLUID LEFT IN THE SYSTEM. THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507221 ↗
• InjuryOct 12, 2021Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE DEVICE NO LONGER WORKING SINCE 2018 AND THE PELVIC REGION WAS VERY IRRITATED. DURING DIAGNOSTIC IMAGING THE PHYSICIAN OBSERVED A FISTULA IN THE URETHRA. THE FISTULA WAS CAUSING THE PATIENT TO URINATE, THE CONNECTOR WAS EMBEDDED IN THE IN THE URETHRA AND HAD ERODED THROUGH THE SCROTUM. THE IPP WAS EXPLANTED AND REPLACED WITH A TACTRA.

  Patient problems: Erosion; Fistula; Skin Inflammation/ Irritation

  MAUDE report 12618496 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A REMOVAL OF HIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER DUE TO EROSION. A RE-IMPLANT SURGERY WAS PERFORMED TO IMPLANT A NEW CYLINDER INTO THE EMPTY SPACE LEFT BY THE PREVIOUS EXPLANT SURGERY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Erosion

  MAUDE report 11597321 ↗
• InjuryFeb 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A WEEK PRIOR TO THE SURGERY THE RIGHT CYLINDER OF AN INFLATABLE PENILE PROSTHESIS (IPP) ERODED INTO THE URETHRA. THE PATIENT WAS ON HONEYMOON AND INDICATED USING THE DEVICE "A GREAT DEAL OF THE TIME". DURING THE PROCEDURE THE TIP OF THE IMPLANT WAS VISIBLE ERODING THROUGH THE RIGHT SIDE OF THE URETHRA. THERE WERE NO SIGNS OF INFECTION. THE PHYSICIAN CUT AND REMOVED THE CYLINDER AND THEN SECURED THE REMAINING TUBING WITH A METAL PLUG. NO OTHER COMPONENTS WERE EXPLANTED. THE PATIENT DID NOT EXPERIENCE FURTHER ADVERSE EVENTS AND WAS SAID TO BE GOOD AFTER THE PROCEDURE.

  Patient problems: Erosion; Perforation

  MAUDE report 9744102 ↗
• InjuryAug 14, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DUE TO PERFORATION IN CYLINDER THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) REMOVED AND REPLACED. THE IPP WAS EXPLANTED AND A NEW DEVICE CONSISTING OF A 18 CM X 12 MM CYLINDERS, PUMP AND RESERVOIR WERE IMPLANTED. IT WAS FURTHER REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8893413 ↗
• InjuryJul 17, 2019Adverse 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 EXPERIENCED UNSPECIFIED ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE DEVICE WAS REMOVED AND A NEW IPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. NO MORE INFORMATION IS AVAILABLE AT THE MOMENT, ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. ADDITIONAL INFORMATION RECEIVED. THE DEVICE WAS REPLACED DUE TO IT STOPPED WORKING, THE SPECIFIC ISSUE IS UNKNOWN. THERE WERE NO PATIENT ADVERSE EFFECTS AND PATIENT IS DOING FINE. THE IMPLANT PROCEDURE OF THE PREVIOUS DEVICE WAS ON (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798438 ↗
• InjuryMay 20, 2019Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPONTANEOUS INFLATION WITH AN INFLATABLE PENILE PROSTHESIS (IPP). A REPLACEMENT SURGERY WAS PERFORMED. THE PATIENT WAS CONCERNED ABOUT A POSSIBLE INFECTION, BUT IT WAS CONFIRMED THAT THE PATIENT DID NOT PRESENT SIGNS OF INFECTION. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE. NO MORE INFORMATION AVAILABLE AT THE MOMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8625595 ↗