AMS 700 CX 72404273Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00878953003801), received between Oct 22, 2018 and Sep 25, 2026 — classified as 72 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (47 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 73 reports, 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 ↗
• 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 ↗
• InjuryNov 5, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; 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 THERE WAS A CRACK IN THE CYLINDER CONNECTING TUBE, THEREFORE; BOTH CYLINDERS AND THE PUMP WERE REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475818 ↗
• InjuryOct 15, 2025Degraded; Mechanical Problem; Nonstandard Device; Degraded; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TESTS WERE PERFORMED AND REVEALED AN ANEURYSM IN THE LEFT CYLINDER; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286588 ↗
• InjuryJun 5, 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 WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT DID NOT WORK PROPERLY. TWO WEEKS LATER, AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE RIGHT CYLINDER CONNECTING TUBE. THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151342 ↗
• InjuryMay 20, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS SURGICAL PROCEDURE PERFORMED TO ADD SALINE ON RESERVOIR DUE TO THE INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER STRENGTH WAS WEAK. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056628 ↗
• InjuryApr 17, 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 WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT DID NOT WORK PROPERLY. TWO WEEKS LATER A SURGERY WAS PERFORMED, AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THE CYLINDER WAS BROKEN. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NOT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858225 ↗
• InjuryFeb 28, 2025Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL, AND IT WAS CONFIRMED THAT THE LEFT CYLINDER HAD A HOLE. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE CYLINDER AND PUMP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21493786 ↗
• InjuryJan 30, 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 THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT WORK PROPERLY. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE RIGHT CYLINDER CONNECTING TUBE. THE RIGHT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276994 ↗
• InjuryNov 14, 2024Mechanical 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 THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. IT WAS CONFIRMED THAT THE CYLINDER HAD A TEAR. THE DEVICE WAS REMOVED AND REPLACED. THE ORIGINAL RESERVOIR WAS KEPT IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686798 ↗
• InjuryNov 14, 2024Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CYLINDER ANEURYSM WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685707 ↗
• InjuryNov 13, 2024Mechanical 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 WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL TWO WEEKS BEFORE THE OPERATION BECAUSE THE PRODUCT DID NOT WORK PROPERLY. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE RESERVOIR CONNECTING TUBE. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NOT PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674263 ↗
• InjuryAug 26, 2024Mechanical 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 RIGHT CYLINDER CONNECTING TUBE WAS FOUND. THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071990 ↗
• InjuryAug 15, 2024Mechanical 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 THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE CYLINDER WAS FOUND. THE IPP WAS REMOVED AND REPLACED WITH A TACTRA, WHILE THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990949 ↗
• InjuryJul 30, 2024Mechanical 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 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 EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19860771 ↗
• InjuryJun 26, 2024Mechanical 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 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 EXPLANTED AND REPLACED, EXCEPT FOR THE RESERVOIR WHICH WAS NOT REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613639 ↗
• InjuryJun 11, 2024Mechanical 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 THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A REVISION SURGERY WAS PERFORMED, DURING WHICH A CRACK IN THE RIGHT CYLINDER CONNECTING TUBE WAS NOTED. CYLINDER AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509927 ↗
• InjuryJun 4, 2024Mechanical 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 THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A TEAR IN BOTH CYLINDERS WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458901 ↗