AMS 700 CX MS Pump 72404281Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00878953003849), received between Jan 29, 2019 and Aug 31, 2026 — classified as 24 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (17 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Inflation Problem; Inadequacy of Device Shape and/or Size

  It was reported that the cylinders of an Inflatable Penile Prosthesis (IPP) were too short, resulting in glans collapse, and that inflation of the device was difficult and extremely painful. A surgical procedure was performed to remove and replace the IPP. No further patient complications were reported.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 50531578 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection following implantation of an Inflatable Penile Prosthesis (IPP). The infection was identified after the procedure incision dehisced, exposing the tubing, and was diagnosed through culture of purulent drainage from the incision site. The physician did not believe the device caused or contributed to the infection. No device issue was reported. As a result, the device was explanted and replaced. No further patient complications were reported.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 50225912 ↗
• InjuryJul 14, 2026Inflation Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE PRESENTED TO THEIR IMPLANTING PHYSICIAN AS THEY WERE UNABLE TO INFLATE THEIR IPP DEVICE. THE PATIENT REPORTED THAT INITIALLY THE PUMP FELT VERY HARD. THE PHYSICIAN PERFORMED A PHYSICAL EXAMINATION AND WAS UNABLE TO INFLATE THE IPP DEVICE WHEN PRESSING THE PUMP. ULTRASOUND STUDIES WERE PERFORMED AND CONFIRMED THAT THE RESERVOIR WAS INTACT AND CONTAINED FLUID INSIDE. THE PHYSICIAN BELIEVED THAT THE MOST LIKELY/SUSPECTED CAUSE WAS THE PUMP COMPONENT. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815532 ↗
• InjuryNov 27, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND UPON INSPECTION, A CRACK WAS IDENTIFIED IN THE CYLINDER CONNECTING TUBE. ALL COMPONENTS WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23668805 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A FULL-BODY FEVER, ALONG WITH SWELLING AND PAIN IN THE SCROTAL AREA. UPON EXAMINATION, AN INFECTION WAS CONFIRMED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fever; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23532549 ↗
• InjuryOct 28, 2025Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NO FUNCTIONING PROPERLY. A SCAN WAS PERFORMED, AND IT WAS IDENTIFIED THAT RESERVOIR HAD RUPTURED AS IT WAS NOT FILLED. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH WAS CONFIRMED THAT THE RESERVOIR WAS COMPLETELY EMPTY. A NEW IPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404935 ↗
• InjuryOct 20, 2025Mechanical Problem; Nonstandard Device; Connection Problem; Mechanical Problem; Nonstandard Device; Connection Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT REBOUND, AND THE DEVICE WAS NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED, WHICH REVEALED THAT THE TUBE CONNECTING THE PUMP TO THE DEVICE HAD BECOME DISCONNECTED. THEREFORE, THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343932 ↗
• InjurySep 9, 2025Inflation Problem; Mechanical Problem; Nonstandard Device; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) COULD NOT BE USED NORMALLY AS IT COULD NOT BE PRESSED, RESULTING IN THE INABILITY OF THE PENIS TO ACHIEVE AN ERECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012199 ↗
• InjuryJul 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM. THE PUMP AND CYLINDERS WERE REMOVED, REPLACED, AND THE ORIGINAL RESERVOIR WAS RETAINED AND REUSED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521360 ↗
• InjuryJul 2, 2025Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND UPON INSPECTION, A CRACK WAS IDENTIFIED IN THE RIGHT CYLINDER CONNECTING TUBE. BOTH CYLINDERS AND THE PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22390932 ↗
• MalfunctionMay 22, 2025Mechanical Problem; Air/Gas in Device; Mechanical Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO ACTIVATE THE DEVICE THREE MONTHS AGO. UPON EXAMINATION, AN EMPTY PUMP WAS OBSERVED WITH AIR LEAKING OUT WHEN PRESSED. A REVISION SURGERY HAS BEEN REQUESTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072530 ↗
• InjuryMay 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) COULD NOT BE USED NORMALLY, THE PUMP COULD NOT BE PRESSURIZED, RESULTING IN THE BODY OF THE PENIS COULD NOT ERECT. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035219 ↗
• InjuryFeb 4, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AFTER SEXUAL INTERCOURSE, THE PATIENT WAS UNABLE TO DEFLATE THE PROSTHESIS, EVEN THE DOCTOR COULD NOT DEFLATE IT. THE PATIENT ALSO EXPERIENCED PAIN AND DISCOMFORT. DUE TO THIS, A SURGICAL PROCEDURE WAS PERFORMED TO REPLENISH THE DEVICE SUCCESSFULLY.

  Patient problems: Discomfort; Pain

  MAUDE report 21305505 ↗
• InjuryMar 20, 2024Collapse; Mechanical Problem; Collapse; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS STOPPED WORKING. THE PATIENT PRESENTED IN-CLINIC AND DEVICE EVALUATION DETERMINED THAT THE PUMP HAD COLLAPSED, INDICATING AN EMPTY RESERVOIR; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940616 ↗
• InjuryDec 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE INFLATABLE PENILE PROSTHESIS (IPP) DUE TO INFECTION. A NEW IPP WAS IMPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 18327788 ↗
• InjurySep 13, 2023Collapse; Deflation Problem; Inflation Problem; Mechanical Problem; Material Deformation; Collapse; Deflation Problem; Inflation Problem; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT AT THE TIME OF ACTIVATION OF THIS INFLATABLE PENILE PROSTHESIS, THE PHYSICIAN WAS UNABLE TO ACTIVATE THE PROSTHESIS AND WAS UNABLE TO INFLATE OR DEFLATE THE DEVICE. THE PHYSICIAN NOTED THAT THE PUMP REMAINED COLLAPSED, THE DEFLATION BUTTON WAS PRESSED, HOWEVER THERE WAS NO SALINE SOLUTION FLOW FROM THE CYLINDERS TO THE RESERVOIR. A DEFLATION MANEUVER WAS ATTEMPTED SEVERAL TIMES WITHOUT ACHIEVING RESULTS. THE PATIENT PRESENTED A LOT OF DISCOMFORT ON PALPATION, SO IT WAS PROPOSED TO PERFORM TROUBLESHOOTING UNDER SEDATION SO AS NOT TO CAUSE HIM MORE DISCOMFORT. DURING THE REVIEW UNDER SEDATION AND AFTER SEVERAL MANEUVERS IT IS DETERMINED THAT THE PUMP WAS NOT WORKING CORRECTLY. THE DEVICE WOULD PARTIALLY INFLATE BUT IT WAS NOT POSSIBLE TO DEFLATE. THE PATIENT WAS EXPECTED TO UNDERGO A REVISION SURGERY, HOWEVER, NO FURTHER DETAILS WERE AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 17737163 ↗
• InjuryNov 1, 2022Mechanical 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 HAD THIS TACTRA REMOVED AND REPLACED DUE TO AN UNSPECIFIED MECHANICAL ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712771 ↗
• InjuryOct 31, 2022Collapse; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Collapse; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ORIGINAL INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT PROCEDURE, THE DEVICE WAS ALREADY PLACED INSIDE THE PATIENT AND A TEST WAS PERFORMED. IT WAS NOTICED THAT THE PUMP IS NOT COMPLETELY FILLED, AND IT REMAINS DIMPLED. THE PHYSICIAN DECIDED TO REMOVE THE IPP AND IMPLANT A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704507 ↗
• InjuryMay 10, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED THREE MONTHS AFTER THE INITIAL IMPLANT, DUE TO INFECTION. THE CYLINDER CROSSED THE CORPORAL BODY OF THE PENIS PERFORATING TISSUE AND EXTRUDED OUT OF THE END OF THE PENIS. ADDITIONALLY, DEVICE INFLATION WAS NOT SMOOTH. FOLLOWING THE PROCEDURE THE PATIENT WAS STABLE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Perforation; Unspecified Infection

  MAUDE report 14347174 ↗
• MalfunctionNov 16, 2021Deflation Problem; Inflation Problem; Mechanical Problem; Deflation Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MECHANICAL ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP). APPROXIMATELY THREE MONTHS POST-IMPLANT, THE PATIENT HAD DEFLATION ISSUES WITH THE DEVICE; HOWEVER, THE PHYSICIAN HELPED THE PATIENT TROUBLESHOOT THE DEVICE. EIGHT MONTHS AGO THE PATIENT EXPERIENCED INFLATION ISSUES WITH THE IPP. AN ASSESSMENT HAS BEEN DONE EVERY TWO MONTHS SINCE BUT THE PROBLEM PERSISTED. THERE HAS BEEN NO INTERVENTION REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822603 ↗
• MalfunctionOct 13, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A REVISION PROCEDURE TO REVISE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PATIENTS INABILITY ACTIVATING THE PUMP. THE PHYSICIAN ATTEMPTED TO INFLATE THE DEVICE WITHOUT SUCCESS. THE IPP REMAINS IMPLANTED AND ACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628028 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED AN EROSION WITH HIS INFLATABLE TWO MONTHS AFTER IMPLANT. PHYSICIAN STATES THE PATIENT WENT INTO A JACUZZI TEN DAYS AFTER THE PROCEDURE. ALL COMPONENTS WERE EXPLANTED AND A NEW TACTRA DEVICE WAS EXPLANTED.

  Patient problems: Erosion

  MAUDE report 11338806 ↗
• InjuryOct 28, 2020Collapse; Fluid/Blood Leak; Inflation Problem; Collapse; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUES WITH AN INFLATABLE PENILE PROSTHESIS(IPP) PUMP. THE PUMP DIDN'T WORK AND THE PATIENT WAS HAVING PROBLEMS SQUEEZING THE PUMP BUT THE CYLINDERS NOT INFLATING. A REVISION SURGERY OCCURRED TO REPLACE THE PUMP AND FLUID LOSS WAS FOUND. A PATIENT OUTCOME OF STABLE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10751799 ↗
• InjuryJul 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE DUE TO UNSPECIFIED REASONS. THE PATIENT IS NOW EXPERIENCING PAIN IN HIS PENIS.

  Patient problems: Pain

  MAUDE report 10299707 ↗
• InjuryJul 6, 2020Collapse; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Collapse; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PUMP REPLACEMENT SURGERY DUE TO A DIMPLED PUMP WITH HIS INFLATABLE PENILE PROSTHESIS (IPP).

  Patient problems: Pain

  MAUDE report 10236434 ↗