AMS 700 CX MS Pump 72404230Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00878953003436), received between Oct 24, 2019 and Apr 1, 2026 — classified as 27 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (13 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFECTION, INFLAMMATION AT PENILE AND SCROTAL INCISION LOCATION. THE PHYSICIAN REMOVED THE CYLINDERS AND RESERVOIR AND THOROUGHLY WASHED WITH ANTIBIOTIC IRRIGATION. THE DEVICE WAS REPLACED WITH A TACTRA MALLEABLE. THERE IS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 24757280 ↗
• InjuryJan 8, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DIFFICULT TO SQUEEZE AND AUTO INFLATED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012633 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION OF THE CYLINDER INTO THE URETHRA. THE PHYSICIAN BELIEVES THE PATIENT LEFT THE DEVICE ACTIVATED FOR PROLONGED PERIODS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE IPP. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 23945786 ↗
• InjuryJun 27, 2025Nonstandard Device; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) REQUIRED REVISION DUE TO A TUBING RUPTURE BETWEEN THE PUMP AND THE RIGHT CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22348795 ↗
• InjuryJan 14, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING DUE TO FLUID LOSS. UPON REVISION, A RUPTURE IN THE CYLINDER WAS VISUALLY IDENTIFIED; THEREFORE, THE IPP WAS REMOVED AND REPLACED WITH A TACTRA. THE CAUSE OF THE RUPTURE IN THE CYLINDER WAS WEAR AND TEAR FROM USE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149619 ↗
• InjuryDec 2, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WASN'T INFLATING PROPERLY. A FLUID LOSS WAS IDENTIFIED BY NO LIQUID IN THE BALLOON. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827992 ↗
• InjuryNov 26, 2024Fluid/Blood Leak; Inflation Problem; Defective Device; Fluid/Blood Leak; Inflation Problem; Defective Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FULLY INFLATING, IT WAS MENTIONED A FLUID LOSS DUE TO THE LEFT CYLINDER WAS DEGLOVED. THE CYLINDERS WERE EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20777294 ↗
• InjuryOct 17, 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 THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY DUE TO FLUID LOSS FROM THE CONNECTION BETWEEN THE CYLINDER AND THE TUBING. CYLINDERS, PUMP AND RESERVOIR WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476280 ↗
• InjuryApr 10, 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) EXPERIENCED FLOPPY GLANS SYNDROME DUE TO THE CYLINDERS BEING TOO SHORT FOR HIS ANATOMY. A REVISION SURGERY WAS PERFORMED TO EXPLANT AND REPLACE THE DEVICE USING LARGER CYLINDERS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19084044 ↗
• InjuryFeb 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER WORKING. CLINICAL EVALUATION IDENTIFIED EROSION OF THE LEFT CYLINDER THROUGH THE URETHRAL MEATUS. THE IPP WAS EXPLANTED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 18622926 ↗
• InjuryNov 29, 2023Inflation Problem; Mechanical Problem; Defective Device; Inflation Problem; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY DUE TO INFLATION ISSUES CAUSED BY THE PUMP BEING HARD TO SQUEEZE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A MALLEABLE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233820 ↗
• InjurySep 7, 2023Degraded; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Degraded; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING PROPERLY. UPON EXPLANT A HOLE AND A LARGE ANEURYSM IN ONE OF THE CYLINDERS WAS FOUND. THE PUMP AND CYLINDERS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703980 ↗
• InjuryApr 12, 2023Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING PROBLEMS WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) AS IT HAS NOT BEEN INFLATING. A REVISION SURGERY WILL BE PERFORMED IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728876 ↗
• MalfunctionFeb 7, 2023Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN WHICH THE INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPLANTED DUE TO INFLATION ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314940 ↗
• InjuryDec 15, 2022Inadequacy of Device Shape and/or Size; Defective Device; Inadequacy of Device Shape and/or Size; Defective Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THE INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PAIN THE PARTNER WAS HAVING DURING INTERCOURSE, AS WELL AS THE IPP NOT BEING HARD OR LONG ENOUGH. A NEW LARGER IPP WAS IMPLANTED THAT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992006 ↗
• InjuryAug 17, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DIFFICULTY WITH PUMPING UP THE DEVICE. IT WAS DETERMINED THAT THE TUBING WAS BROKEN AT THE TUBING CONNECTION. THE IPP WAS EXPLANTED AND REPLACED WITH A NEW IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246100 ↗
• InjuryAug 16, 2022Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REPLACEMENT SURGERY DUE TO THE DEVICE NOT LONGER INFLATING. IT WAS FOUND THAT THERE WAS A FLUID LEAK CAUSED BY A HOLE IN TUBING. A NEW IPP WAS IMPLANTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237722 ↗
• InjuryMay 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A REPLACEMENT SURGERY TO RE-IMPLANT AN AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) DUE TO FLUID LOSS. THERE WERE NO PATIENT COMPLICATIONS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347848 ↗
• InjuryDec 2, 2021Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT INFLATE THE INFLATABLE PENILE PROSTHESIS (IPP) DEVICE. A REVISION SURGERY HAS BEEN REQUESTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12918902 ↗
• InjuryJul 15, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO DISCOMFORT AND PAIN AS THE DEVICE SETTLED WITH THE TUBING WAS MID SHAFT OF THE PENIS. DURING THE SURGICAL INTERVENTION IT WAS DETERMINED THAT THE CORPOROTOMY FROM THE ORIGINAL IMPLANT MAY HAVE LED TO THIS DISCOMFORT BECAUSE OF WHERE THE TUBING CAME OUT OF THE CORPORA. THE PUMP WAS RIDING HIGH IN THE SCROTUM. A NEW INFLATABLE PENILE PROSTHESIS CONSISTING OF CYLINDERS, PUMP, AND RESERVOIR WAS IMPLANTED. FOLLOWING THE SURGERY, THE PATIENT FULLY RECOVERED.

  Patient problems: Discomfort; Pain

  MAUDE report 12172787 ↗
• InjuryApr 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PUMP NOT WORKING. THE IPP CYLINDER, PUMP, AND RESERVOIR WAS EXPLANTED AND REPLACED WITH A NEW IPP CYLINDER, PUMP, AND RESERVOIR.

  Patient problems: Insufficient Information

  MAUDE report 11735604 ↗
• InjuryJan 13, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REVISED DUE TO A STICKY PUMP.

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

  MAUDE report 11163245 ↗
• InjuryJan 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO INFLATION ISSUES. THE IPP PUMP WAS EXPLANTED AND REPLACED WITH A NEW IPP PUMP. THE PATIENTS STATUS WAS SATISFACTORY FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11110905 ↗
• InjurySep 2, 2020Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT DUE TO A MALFUNCTIONING PUMP CAUSING THE DEVICE TO NOT INFLATE, THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) EXPLANTED. THE PATIENT'S OUTCOME FOLLOWING THIS PROCEDURE WAS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10485300 ↗
• InjuryJul 5, 2020Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS WAS REMOVED DUE TO MALFUNCTION. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10231260 ↗