AMS 700 CXRecalls & reported problems across all models

We found 6 models of AMS 700 CX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Oct 22, 2018 and Sep 25, 2026 — classified as 129 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (87 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 CX problems

AMS 700 CX models

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

• AMS 700 CX 72404273

  Prosthesis, Penis, Inflatable
  73 reports
• AMS 700 CX 72404272

  Prosthesis, Penis, Inflatable
  43 reports
• AMS 700 CX 72404274

  Prosthesis, Penis, Inflatable
  6 reports
• AMS 700 CX 72404172

  Prosthesis, Penis, Inflatable
  5 reports
• AMS 700 CX 72404173

  Prosthesis, Penis, Inflatable
  4 reports
• AMS 700 CX 72404174

  Prosthesis, Penis, Inflatable
  1 report

Recent AMS 700 CX adverse event reports

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

• InjurySep 25, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) went to the hospital because the product was not functioning properly. Two weeks later upon inspection, it was confirmed that the cylinder had a hole, so all components were removed and replaced. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893171 ↗
• InjurySep 21, 2026Mechanical Problem; Material Puncture/Hole

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) presented with a nonfunctioning device. A revision surgery was performed, during which the physician confirmed that a crack was found in the cylinder connecting tube, so the device was replaced. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841473 ↗
• InjuryAug 21, 2026Mechanical Problem; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374582 ↗
• InjuryJun 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) RIGHT CYLINDER PERFORATED THE PATIENT'S URETHRA. A SURGICAL PROCEDURE WAS PERFORMED, A CYSTOSCOPE WAS INSERTED INTO THE URETHRA, AND A TEAR WAS FOUND IN THE RIGHT CORPUS CAVERNOSUM CAVITY. THE RIGHT CYLINDER WAS EXPLANTED A DRAINAGE TUBE WAS LEFT IN PLACE, AND THE PATIENT WAS LEFT WITH A NEW SINGLE CYLINDER. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Perforation; Urinary Retention

  MAUDE report 25486759 ↗
• InjuryJun 4, 2026Mechanical 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 CRACK WAS FOUND IN THE PUMP CONNECTING TUBE. THE PUMP WAS REPLACED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394946 ↗
• InjuryApr 28, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO THE HOSPITAL WITH A NON-FUNCTIONAL DEVICE. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED AND UPON INSPECTION, THERE WAS A TEAR FOUND IN THE LEFT CYLINDER. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED THE ENTIRE DEVICE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019450 ↗
• InjuryMar 31, 2026Mechanical Problem; Nonstandard Device; 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 CRACK WAS FOUND IN THE PUMP CONNECTING TUBE. ALL IPP COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744489 ↗
• InjuryFeb 24, 2026Mechanical Problem; Nonstandard Device; 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 CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF THE HOLE WAS NOT DETAILED BY THE HOSPITAL. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428413 ↗
• InjuryFeb 6, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE CYLINDER CONNECTING TUBE WAS FOUND. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279352 ↗
• InjuryFeb 5, 2026Mechanical 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 and the pump connecting tube. Both the cylinder and the pump were explanted and replaced. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266368 ↗
• InjuryJan 23, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. DURING THE SURGICAL PROCEDURE, A HOLE WAS IDENTIFIED IN THE RIGHT CYLINDER. THE RIGHT CYLINDER AND THE PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162306 ↗
• InjuryJan 23, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE RIGHT CYLINDER CONNECTING TUBE WAS FOUND. THE PUMP AND RIGHT CYLINDER WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159994 ↗
• InjuryDec 4, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE PUMP CONNECTING TUBE WAS FOUND. THE IPP WAS REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT AND A NEW ONE WAS ADDED TO THE SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722426 ↗
• InjuryDec 3, 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, IT WAS CONFIRMED THAT THE CYLINDER HAD A TEAR. 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 23703958 ↗
• InjuryNov 10, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; 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 CRACK IN THE CYLINDER CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF THE CRACK IN THE CONNECTING TUBE 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 23511893 ↗

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