AMS 700 Spherical ReservoirRecalls & reported problems across all models

We found 4 models of AMS 700 Spherical Reservoir by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 293 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2017 and Sep 28, 2026 — classified as 275 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (94 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 Spherical Reservoir problems

AMS 700 Spherical Reservoir models

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

• AMS 700 Spherical Reservoir 72404155

  Prosthesis, Penis, Inflatable
  120 reports
• AMS 700 Spherical Reservoir 72404161

  Prosthesis, Penis, Inflatable
  105 reports
• AMS 700 Spherical Reservoir 72404156

  Prosthesis, Penis, Inflatable
  63 reports
• AMS 700 Spherical Reservoir 72404162

  Prosthesis, Penis, Inflatable
  5 reports

Recent AMS 700 Spherical Reservoir adverse event reports

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

• InjurySep 28, 2026Migration

  Patient problems: Pain

  MAUDE report 50918411 ↗
• InjurySep 22, 2026Migration

  It was reported that the reservoir of this Inflatable Penile Prosthesis (IPP) migrated from the prevesical space into the patient's perineum. A surgical procedure was performed during which the existing reservoir was explanted and replaced with a new one. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855109 ↗
• InjuryAug 11, 2026Migration

  It was reported that the patient implanted with this Inflatable Penile Prosthesis (IPP) was dissatisfied because the reservoir tubing was palpable. A surgical revision procedure was performed, during which no device issue was identified, and the device was confirmed to be functioning as intended. However, the reservoir was removed and repositioned, with the tubing placed in a deeper location. No additional information was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209651 ↗
• InjuryAug 3, 2026Inflation Problem

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) was unable to inflate the device. During revision surgery, no fluid was observed moving into the cylinders. The device was disconnected from the reservoir, and surrogate testing was performed, after which the cylinders inflated. An attempt was made to aspirate fluid from the reservoir; however, no fluid could be retrieved. As a result, the reservoir was capped and retained in situ, and a new reservoir was implanted on the left side. Following implantation of the new reservoir, the device inflated properly. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123761 ↗
• 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 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED RESERVOIR DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE ENTIRE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 25602212 ↗
• InjuryJun 5, 2026Migration

  IT WAS REPORTED THAT A PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR PREVIOUSLY LOCATE IN THE SPACE OF RETZIUS WAS NOW PUSHING THE BLADDER. A SURGICAL PROCEDURE WAS PERFORMED, AND THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415211 ↗
• InjuryMay 28, 2026Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISSATISFACTION WITH THE RESERVOIR BULGE. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE RESERVOIR. NO DEVICE ISSUES WERE IDENTIFIED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325637 ↗
• InjuryMay 27, 2026Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR HERNIATED. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311221 ↗
• InjuryApr 29, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A HERNIA ASSOCIATED WITH THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE EXISTING DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038291 ↗
• 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 ↗
• InjuryApr 10, 2026Migration

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE EXPERIENCED BLADDER PAIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN IDENTIFIED THAT THE RESERVOIR HAD ERODED INTO THE BLADDER. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion; Pain

  MAUDE report 24841808 ↗
• InjuryApr 8, 2026Migration

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED A RESERVOIR MIGRATION, WHICH RESULTED IN A BOWEL OBSTRUCTION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS REMOVED. IT WAS ALSO NOTED THAT THE CYLINDERS WERE LEFT SEMI-INFLATED, AND A METAL CAP WAS PLACED ON THE CYLINDER TUBING JUST BENEATH THE ABDOMINAL COUNTER INCISION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24818373 ↗

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