AMS 700 CXRRecalls & reported problems across all models

We found 4 models of AMS 700 CXR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 886 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2018 and Sep 30, 2026 — classified as 876 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (554 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AMS 700 CXR problems

AMS 700 CXR models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AMS 700 CXR 72404013

  Prosthesis, Penis, Inflatable
  381 reports
• AMS 700 CXR 72404014

  Prosthesis, Penis, Inflatable
  233 reports
• AMS 700 CXR 72404012

  Prosthesis, Penis, Inflatable
  212 reports
• AMS 700 CXR 72404011

  Prosthesis, Penis, Inflatable
  60 reports

Recent AMS 700 CXR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Deformation; Migration

  It was reported that patient experienced bulging and disfigurement in the penile body with the Inflatable Penile Prosthesis (IPP). Upon revision, physician noticed that the reservoir wasn't placed correctly and caused a bulge in the abdominal cavity. Per additional information, it was later reported that also the polyester braided layer inside the cylinder ruptured, resulting in column deformation. As a result, the device was explanted and replaced. No further complications were reported.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50947808 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  It was reported that the patient with an Inflatable Penile Prosthesis (IPP) had a cylinder eroded into the urethra and was associated with an infection. A revision procedure was performed during which the device was explanted. Following the procedure, the patient developed infectious symptoms. No additional information regarding the procedure outcome or event resolution was reported.

  Patient problems: Erosion; Perforation; Unspecified Infection

  MAUDE report 50893025 ↗
• InjurySep 24, 2026Mechanical Problem; Nonstandard Device; 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 tear was identified in the right cylinder. All components were explanted and replaced. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885563 ↗
• InjurySep 22, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with a nonfunctioning device that would not inflate. A revision surgery was performed, during which the physician suspected a fluid leak within the system. The device was explanted and replaced. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857421 ↗
• InjurySep 21, 2026Degraded; Mechanical Problem; Nonstandard Device

  It was reported that the Inflatable Penile Prosthesis (IPP) was not functioning. A revision procedure was performed, during which it was confirmed that the right cylinder had a bulge. All components were removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843216 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed a fungus infection in the scrotum. A surgical procedure was performed to remove and replaced the IPP. The infection was treated with antibiotics. No further patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50673191 ↗
• InjurySep 8, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient went to the clinic because this Inflatable Penile Prosthesis (IPP) was not working properly. Two weeks later, a surgical procedure was performed, during which a hole in the cylinder was identified. The cause of the cylinder hole was not detailed by the hospital. All the components were removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668391 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed a collection of pus in the tissue. A surgical procedure was performed to remove the IPP. No further patient complications were reported.

  Patient problems: Purulent Discharge

  MAUDE report 50612085 ↗
• InjurySep 3, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599732 ↗
• InjurySep 1, 2026Inflation Problem

  It was reported that a patient's Inflatable Penile Prosthesis (IPP) exhibited inflation issues observed in the cylinders and pump due to a blockage in either the cylinders or the pump. A surgical procedure was performed to replace the preconnect. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50553503 ↗
• InjurySep 1, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. During a surgical procedure, a hole was identified in the left cylinder. As a result, both cylinders and the pump were replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50553494 ↗
• InjuryAug 31, 2026Fluid/Blood Leak

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) developed an infection in the penis, and the device exhibited fluid loss. A surgical procedure was performed to remove and replace the IPP. The infection was treated with antibiotic therapy. No further patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50533590 ↗
• InjuryAug 31, 2026Migration

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) cylinder protruded through the distal aspect of the penis. A surgical procedure was performed during which the IPP was explanted. Reimplantation of a new device was planned for a later date. It was reported that the extrusion was attributed to device displacement resulting from long-term wear. No additional patient complications were reported.

  Patient problems: Erosion; Unspecified Tissue Injury

  MAUDE report 50515458 ↗
• InjuryAug 24, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. During a surgical procedure, it was determined that the right cylinder had a hole. The right cylinder and pump were subsequently replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408010 ↗
• InjuryAug 19, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) was not functioning properly. During a surgical procedure, a hole was identified in one of the cylinders. As a result, the IPP was fully replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326182 ↗

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