AMS 700 CX 72404272Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00878953003795), received between Dec 10, 2018 and Mar 31, 2026 — classified as 42 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (34 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 43 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 24, 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 23381859 ↗
• InjurySep 16, 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 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 TEAR WAS FOUND IN THE CYLINDER. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069694 ↗
• InjuryAug 18, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Nonstandard Device; 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 THE RIGHT CYLINDER HAD A HOLE, SO ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828902 ↗
• InjuryJul 22, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS IPP EXHIBITED LOW CYLINDER STRENGTH; THEREFORE, A SURGICAL PROCEDURE WAS PERFORMED TO ADD ADDITIONAL SALINE TO THE RESERVOIR. NO COMPONENTS WERE REMOVED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562474 ↗
• InjuryJul 14, 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 VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT WORK PROPERLY. TWO WEEKS LATER, THE PATIENT UNDERWENT SURGERY, AND A HOLE WAS IDENTIFIED IN THE LEFT CYLINDER. AS A RESULT, BOTH CYLINDERS AND THE PUMP WERE REPLACED DURING THE PROCEDURE. THE CAUSE OF THE CYLINDER HOLE WAS NOT DETAILED BY THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501958 ↗
• InjuryJul 7, 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 A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS IPP PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED A CRACK IN THE RIGHT CYLINDER CONNECTING TUBE. 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 22414157 ↗
• InjuryJun 3, 2025Mechanical Problem; Material Puncture/Hole; Mechanical 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 TEAR IN THE CYLINDER WAS IDENTIFIED. ALL THE COMPONENTS WERE REMOVED AND REPLACED. THE CAUSE OF THE CYLINDER TEAR WAS NOT DETAILED BY THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134102 ↗
• InjuryApr 9, 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 DURING A SURGICAL PROCEDURE, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE INFLATABLE PENILE PROSTHESIS (IPP) RIGHT CYLINDER CONNECTING TUBE, THE RIGHT CYLINDER AND A PUMP WERE REPLACED ACCORDING TO THE DOCTOR DIAGNOSIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21809330 ↗
• InjuryApr 3, 2025Inflation Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INABILITY TO INFLATE HIS INFLATABLE PENILE PROSTHESIS (IPP) DEVICE. A REVISION SURGERY WAS PERFORMED IN WHICH THE PHYSICIAN CONFIRMED THAT THE CYLINDER HAD A TEAR. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761838 ↗
• InjuryOct 22, 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 CRACK IN THE CYLINDER CONNECTING TUBE WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505412 ↗
• InjuryAug 27, 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 20075875 ↗
• InjuryAug 23, 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 RIGHT CYLINDER 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 20047140 ↗
• InjuryJul 1, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  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 LEFT CYLINDER CONNECTING TUBE WAS NOTED. CYLINDERS AND PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652736 ↗
• InjuryJun 18, 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 CYLINDER CONNECTING TUBE WAS FOUND. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557768 ↗
• InjuryJun 11, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A REVISION SURGERY WAS PERFORMED, DURING WHICH A HOLE IN THE LEFT CYLINDER 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 19509611 ↗
• InjuryFeb 22, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE INFLATABLE PENILE PROSTHESIS CYLINDER AND PUMP WERE REMOVED AND REPLACED DUE TO A TEAR IN THE RIGHT CYLINDER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757228 ↗
• InjuryAug 29, 2023Degraded; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Degraded; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO THE INFLATABLE PENILE PROSTHESIS (IPP) NOT WORKING APPROPRIATELY. TWO WEEKS LATER, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE PUMP AND CYLINDERS WERE REPLACED. UPON EXPLANT, A CYLINDER BULGE WAS NOTED; HOWEVER, ITS CAUSE WAS NOT DETAILED BY THE FACILITY. IT WAS NOTED THAT DURING THE SURGERY A SET OF CYLINDERS WERE ACCIDENTALLY DROPPED ON THE FLOOR; THEREFORE, A DIFFERENT IPP WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639937 ↗
• InjuryMay 25, 2023Material 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 BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH A TEAR IN THE CYLINDER WAS NOTED. THE CYLINDERS AND THE PUMP WERE REMOVED AND REPLACED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003611 ↗
• InjuryMar 28, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED IN WHICH A CRACK IN THE CONNECTING TUBE OF THE LEFT CYLINDER WAS CONFIRMED. AS A RESULT, THE PUMP WAS REMOVED AND REPLACED. THE CAUSE OF THE CONNECTING TUBE ISSUE WAS NOT DETAILED BY THE HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629981 ↗