AMS 700 Spherical Reservoir 72404161Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00878953003238), received between Jan 10, 2019 and Jul 7, 2026 — classified as 102 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (74 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 105 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 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 RESERVOIR CONNECTING TUBE, SO THE RESERVOIR WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740461 ↗
• InjuryJun 24, 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 FOUND A CRACK IN THE RESERVOIR CONNECTING TUBE. THE RESERVOIR WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25603645 ↗
• InjuryApr 24, 2026Mechanical 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 HOLE IN THE RESERVOIR WAS FOUND. THE PUMP 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 24988287 ↗
• InjuryApr 23, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR WAS REPLACED DUE TO A LINE HOLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967549 ↗
• InjuryMar 13, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED PAIN AND A SENSATION OF A MASS/LUMP IN THE INGUINAL REGION. THE PAIN WAS UNCOMFORTABLE BUT WAS NOT SEVERE OR ACUTE SUCH THAT IT REQUIRED TREATMENT. UPON EXAMINATION, THE PHYSICIAN REPORTED THAT THE RESERVOIR HAD SHIFTED/MOVED. THE RESERVOIR WAS PREVIOUSLY LOCATED IN THE SPACE OF RETZIUS, AND HAD MIGRATED TO THE INGUINAL REGION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS REPOSITIONED, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 24594633 ↗
• InjuryMar 11, 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 REPLACED THE PUMP AND RESERVOIR DUE TO CRACKS IN THE TUBING BETWEEN THE RIGHT CYLINDER AND THE PUMP. THE PHYSICIAN SUSPECTED THAT THE DURABILITY OF THE PRODUCT ITSELF WAS THE CAUSE OF THE REPORTED ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571686 ↗
• InjuryFeb 24, 2026Migration

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR EXHIBITED A MIGRATION. A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE RESERVOIR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430135 ↗
• InjuryJan 6, 2026Material Deformation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS EXPERIENCING ISSUES RELATED TO A FOLDING PROBLEM IN THE TUBING CONNECTED TO THE PUMP AND RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE LENGTH OF THE RESERVOIR TUBING WAS ADJUSTED TO ADDRESS THE FOLDING. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973408 ↗
• InjuryNov 27, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical 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 IDENTIFIED IN THE CYLINDER CONNECTING TUBE. THE RESERVOIR WAS REPLACED IN ACCORDANCE WITH THE PHYSICIAN'S DIAGNOSIS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667608 ↗
• InjurySep 10, 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) WAS NOT FUNCTIONING PROPERLY. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND UPON INSPECTION, A CRACK WAS IDENTIFIED IN THE RESERVOIR CONNECTING TUBE. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE RESERVOIR AND PUMP WERE REPLACED, WHILE THE RETAINED RESERVOIR WAS LEFT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018390 ↗
• InjuryJul 8, 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) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN RESERVOIR WAS FOUND. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439494 ↗
• 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 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 RESERVOIR CONNECTING TUBE. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22427306 ↗
• InjuryJul 1, 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 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 RESERVOIR WAS IDENTIFIED. THE CAUSE OF THE 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 22377632 ↗
• InjuryJun 21, 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 HOLE IN THE RESERVOIR WAS IDENTIFIED. THE CAUSE OF THE HOLE WAS NOT DETAILED BY THE HOSPITAL. THE PUMP WAS REMOVED AND REPLACED, AND A NEW RESERVOIR WAS PLACED, BUT THE ORIGINAL WAS KEPT IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303484 ↗
• InjuryJun 19, 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 HOLE IN RESERVOIR WAS FOUND. THE IPP WAS REMOVED AND REPLACED, THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294390 ↗
• InjuryJun 18, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR HAD A HOLE. CYLINDERS AND PUMP WERE REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT AND A NEW ONE WAS ADDED TO THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282399 ↗
• InjuryJun 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 A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR HAD A HOLE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE RESERVOIR WAS LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22242148 ↗
• InjuryJun 10, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR HAD A HOLE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179264 ↗
• InjuryJun 9, 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 HOLE IN THE RESERVOIR WAS FOUND. THE PUMP AND THE RESERVOIR WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171957 ↗
• InjuryMay 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 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. BOTH CYLINDER AND PUMP WERE REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT AND A NEW ONE WAS ADDED TO THE SYSTEM. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035197 ↗
• InjuryFeb 13, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT WORK PROPERLY. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THE RESERVOIR HAD A HOLE. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375476 ↗
• InjuryJan 28, 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) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE RESERVOIR CONNECTING TUBE WAS FOUND. THE RESERVOIR AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255230 ↗
• InjuryDec 18, 2024Mechanical 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 HOLE IN THE RESERVOIR WAS IDENTIFIED. THE CAUSE OF THE HOLE WAS NOT DETAILED BY THE HOSPITAL. THE RESERVOIR AND THE PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968372 ↗
• InjuryNov 15, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT WORK PROPERLY. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A CRACK IN THE RESERVOIR CONNECTING TUBE WAS FOUND. 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 20696133 ↗
• InjuryOct 10, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT, WHO HAD AN INFLATABLE PENILE PROSTHESIS (IPP) DEVICE, HAD AN INFECTION. THE ENTIRE IPP DEVICE WAS EXPLANTED, AND A NEW IPP DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 20424251 ↗