AMS 700 CX MS Pump 72404234-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 00878953009803), received between Jan 7, 2019 and Sep 29, 2026 — classified as 135 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (42 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 144 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fluid/Blood Leak; Inflation Problem; Material Deformation; Migration; Air/Gas in Device

  It was reported that this patient with an Inflatable Penile Prosthesis (IPP) came into a postoperative visit two weeks later with a hematoma, swelling, and the pump was displaced posteriorly. Two months post implant surgery the swelling had subsided. The patient returned to the clinic on (b)(6) 2026, and they could not inflate the cylinders by themselves, and they had discomfort in the perineum. A surgical procedure was performed. During the surgery, the physician noted the tubing was twisted and folded/retracted on itself on the right proximal top of the perineum, and there was a air and a leak in the system. No additional information was provided.

  Patient problems: Discomfort; Hematoma; Swelling/ Edema

  MAUDE report 50936905 ↗
• InjurySep 29, 2026Migration

  It was reported that the cylinders of an Inflatable Penile Prosthesis (IPP) herniated into the patient's scrotum and outside the corpora. The patient does not know how it happened. A surgical procedure was performed to remove and replace the IPP. No further patient complications were reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50933129 ↗
• InjurySep 24, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891979 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Inflatable Penile Prosthesis (IPP) eroded through the scrotum. A surgical procedure was performed during which the existing device was explanted and replaced with a new IPP. There were no further patient complications reported.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 50759111 ↗
• InjuryAug 14, 2026Inflation Problem

  It was reported that an Inflatable Penile Prosthesis (IPP) exhibited inflation issues. 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 50260558 ↗
• InjuryAug 5, 2026Inflation Problem; Mechanical Problem; Human-Device Interface Problem; Failure to Deflate

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. The patient also reported having undergone multiple replacement procedures since 1995, including a revision on (b)(6) 1998 and subsequent surgeries on (b)(6) 2014 and (b)(4) 2018. The patient stated that during a previous revision procedure on the physician was unable to locate the reservoir from an earlier implant and elected to leave it in place. Following the procedure, the patient experienced significant pain and expressed dissatisfaction with the post-operative care provided. The patient further reported that the pump felt extremely hard after surgery and was very difficult to manipulate in order to deflate or soften. Subsequently, the device was evaluated by another physician, who agreed that the IPP was no longer functioning properly, as it would neither pump nor inflate. However, this physician no longer performs IPP surgeries. The patient was provided with information for specialists in the area to obtain a second opinion. No additional patient complications were reported.

  Patient problems: Pain

  MAUDE report 50142810 ↗
• InjuryJul 29, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. A surgical procedure was performed during which a fluid loss due a cylinder puncture was identified. It was reported that the puncture was due to the patient getting penile girth injections and puncturing implant. The preconnect system was replaced and the reservoir was retained. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075348 ↗
• InjuryJul 17, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT AND PAIN ASSOCIATED WITH THE LEFT CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS DETERMINED THAT THE LEFT CYLINDER WAS OVERSIZED. AS A RESULT, THE IPP WAS EXPLANTED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 25857810 ↗
• InjuryMay 5, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Inadequacy of Device Shape and/or Size; Malposition of Device; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED DISSATISFACTION STATED THEY WERE UNABLE TO USE DEVICE. COMPUTED TOMOGRAPHY SCAN SHOWED POTENTIAL AIR IN THE DEVICE. UPON REMOVAL, A SMALL LEAK WAS LOCATED IN THE TUBING NEAR THE PUMP. THE CYLINDERS WERE ALSO FOLDED OVER THEMSELVES IN THE CORPORA. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082299 ↗
• InjuryApr 9, 2026Collapse; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PUMP BULB OF AN INFLATABLE PENILE PROSTHESIS (IPP) REMAINED FLAT DURING ATTEMPTED INFLATION, AND THE DEVICE EXHIBITED FLUID LOSS AT THE CONNECTION SITE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A HOLE EXTENDING FROM THE RIGHT CYLINDER TO THE PUMP WAS OBSERVED. AS A RESULT, THE PUMP, TUBING, AND RESERVOIR WERE REMOVED AND REPLACED. THE CYLINDERS REMAINED IMPLANTED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831197 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFECTION IN THE PENOSCROTAL INCISION SITE OF THE ORIGINAL SURGERY, PAIN, SWELLING AND PURULENT DRAINAGE. AS A RESULT, THE DEVICE WAS EXPLANTED, THE AREA WAS WASHED OUT, AND A TACTRA WAS PLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24623809 ↗
• InjuryFeb 24, 2026Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM DUE TO FLUID LOSS IN THE RIGHT CYLINDER. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436522 ↗
• InjuryJan 22, 2026Nonstandard Device; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED HERNIATION OF A CYLINDER OUT OF THE CORPOROTOMY. THE CYLINDER ON THE RIGHT-SIDE WAS NO LONGER POSITIONED WITHIN THE CORPORAL BODY. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED WITH A NEW SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145704 ↗
• InjuryJan 7, 2026Inflation Problem; Material Puncture/Hole; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED INFLATION ISSUES IN ONE CYLINDER, ALSO THE PATIENT NOTED THAT IT WOULD DEFLATE DURING USE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A RUPTURE IN THE LEFT CYLINDER WAS IDENTIFIED. THE CYLINDERS AND PUMP WERE REPLACED, WHILE THE RESERVOIR WAS PRESERVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989035 ↗
• InjuryDec 15, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED KINKING IN THE LEFT CYLINDER AT THE SITE OF THE PREVIOUS GRAFT. THE GRAFTING WAS SUSPECTED TO BE THE CAUSE OF THE KINKING. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810887 ↗
• InjuryDec 8, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED AN INFLATION PROBLEM DUE TO FLUID LOSS AT TUBING TO CYLINDERS. THE IPP WAS EXPLANTED AND REPLACED, THE OLD RESERVOIR WAS DRAINED AND RETAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744641 ↗
• InjuryDec 1, 2025Deflation Problem; Unintended Deflation; Deflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DEFLATION DURING INTERCOURSE. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH THE CYCLING FUNCTION WAS FOUND TO BE NORMAL BUT DID NOT MAINTAIN PRESSURE. NO LEAKS OR AIR WERE DETECTED IN THE SYSTEM, AND THE PUMP DID NOT REMAIN FLAT. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A NEW IPP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681822 ↗
• InjurySep 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE PATIENT THAT HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WAS NOT FUNCTIONING. FOLLOWING A CONSULTATION WITH THE PHYSICIAN, A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS SCHEDULED. THE PATIENT SUBSEQUENTLY UNDERWENT A DEVICE REPLACEMENT SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23148799 ↗
• InjuryAug 25, 2025Inflation Problem; Mechanical Problem; Nonstandard Device; Inflation Problem; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS IPP PRESENTED WITH A DEVICE THAT DID NOT INFLATE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE DEVICE DID NOT INFLATE DUE TO THE PUMP NOT TRANSFERRING FLUID TO THE CYLINDERS. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891032 ↗
• InjuryJul 2, 2025Inadequacy 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 PAIN AND PENILE CURVATURE. THE ORIGINAL IMPLANT WAS SLIGHTLY TOO LARGE. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 22385925 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION OF THE RIGHT CYLINDER IN THE DISTAL PORTION OF THE URETHRA, AND THE CYLINDER WAS VISIBLY EXTRUDING THE GLANS OF THE PENIS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP. A FULL WASHOUT WAS PERFORMED, THE PATIENT WAS REMEASURED, AND A MALLEABLE CYLINDER WAS INSERTED ON PATIENT'S LEFT CORPORAL BODY ONLY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22290559 ↗
• MalfunctionMay 15, 2025Collapse; Air/Gas in Device; Collapse; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) CAME TO HIS DOCTOR OFFICE AFTER HE HEARD AND FELT SOMETHING DIFFERENT DURING INFLATION OF HIS DEVICE. THE PHYSICIAN MADE A REVISION HE FELT LIKE THERE WAS AIR IN THE DEVICE, BUT IT STILL INFLATED AND DEFLATED OKAY. THE SALES REP CHECKED TOO, AND SHE OBSERVED A CLICKING NOISE AND FEEL WHEN SQUEEZING THE PUMP. AFTER A HANDFUL OF SQUEEZES, THE PUMP STAYED DEPRESSED. THE PHYSICIAN CYCLED BACK AND FORTH BETWEEN THE DEFLATION BUTTON AND PUMP MULTIPLE TIMES. THIS RESOLVED THE SEMI-FLAT PUMP. CLICK STILL CONTINUED BUT DEVICE INFLATED AND DEFLATED AS IT SHOULD. THE DOCTOR WILL FOLLOW UP IF NEEDED. THE DEVICE IS STILL IMPLANTED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029937 ↗
• InjuryApr 23, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS NO LONGER ABLE TO PUMP HIS INFLATABLE PENILE PROSTHESIS DEVICE DUE TO A FLUID LOSS WITHIN THE SYSTEM. DURING THE REVISION SURGERY, THE PHYSICIAN IDENTIFIED A HOLE IN THE CYLINDER, WHICH WAS DETERMINED TO BE THE CAUSE OF THE FLUID LOSS. THE PHYSICIAN ATTRIBUTED THE HOLE TO REPEATED USE OF THE DEVICE. CONSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892719 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN TO INSERTION SITE. THE IPP WAS EXPLANTED AND REPLACED WITH TACTRA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 21607692 ↗
• InjuryMar 14, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS INFLATABLE PENILE PROSTHESIS IPP UNDERWENT A SURGICAL PROCEDURE TO REPLACE THEIR DEVICE WITH A SMALLER IPP AS IT WAS SUSPECTED THE PATIENT HAD AN OVERSIZED IMPLANT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605278 ↗