AMS 700 LGXRecalls & reported problems across all models
Boston Scientific Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 194
- Deaths reported
- 0
- Injuries reported
- 192
- Recalls
- 0
We found 6 models of AMS 700 LGX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 194 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2018 and Sep 24, 2026 — classified as 192 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (134 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
Reports received per month, all models
Most reported AMS 700 LGX problems
Device problems
- Material Puncture/Hole134
- Mechanical Problem120
- Adverse Event Without Identified Device or Use Problem56
- Fluid/Blood Leak31
- Inflation Problem15
- Nonstandard Device10
- Insufficient Device Problem Information8
- Defective Device7
Patient problems
- No Clinical Signs, Symptoms or Conditions143
- No Known Impact Or Consequence To Patient26
- No Consequences Or Impact To Patient14
- Pain10
- Unspecified Infection7
- Inflammation4
- Discomfort1
- Fibrosis1
AMS 700 LGX models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 700 LGX 72404292Prosthesis, Penis, Inflatable135 reports
- AMS 700 LGX 72404293Prosthesis, Penis, Inflatable46 reports
- AMS 700 LGX 72404291Prosthesis, Penis, Inflatable8 reports
- AMS 700 LGX 72404241Prosthesis, Penis, Inflatable3 reports
- AMS 700 LGX 72404242Prosthesis, Penis, Inflatable1 report
- AMS 700 LGX 72404243Prosthesis, Penis, Inflatable1 report
Recent AMS 700 LGX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Mechanical Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892210 ↗InjurySep 23, 2026Mechanical Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876376 ↗InjuryAug 26, 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, so the pump was replaced. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50460815 ↗InjuryJun 30, 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 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 25673418 ↗InjuryJun 25, 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 RIGHT CYLINDER CONNECTING TUBE. THE RIGHT CYLINDER AND THE PUMP WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630741 ↗InjuryJun 11, 2026Nonstandard Device
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER STRENGTH WAS WEAK. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE SURGEON ADDED ADDITIONAL SALINE SOLUTION TO THE IPP, ALL COMPONENTS WERE RETAINED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480016 ↗InjuryJan 22, 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 IDENTIFIED IN THE RIGHT CYLINDER CONNECTING TUBE. THE RIGHT CYLINDER AND THE PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148705 ↗InjuryJan 19, 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 CRACK IN THE CYLINDER CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF THE CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111850 ↗InjuryJan 5, 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 CYLINDER WAS FOUND. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956206 ↗InjuryNov 13, 2025Inflation Problem; Inflation Problem
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 CYLINDER. NO COMPONENTS WERE REMOVED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543344 ↗InjuryNov 12, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NO LONGER FUNCTIONING. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK WAS IDENTIFIED IN THE CYLINDER CONNECTING TUBE. AS A RESULT, THE PUMP WAS REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS LEFT IN PLACE AND A NEW ONE WAS ADDED TO THE SYSTEM. NO PATIENT COMPLICATIONS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534349 ↗InjuryOct 21, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; 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 PUMP CONNECTING TUBE. THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23346987 ↗InjuryOct 17, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical 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 WAS FOUND. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323035 ↗InjuryOct 15, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical 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 LEFT CYLINDER CONNECTION TUBE 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 23286449 ↗InjurySep 23, 2025Mechanical Problem; Nonstandard Device; Material Puncture/Hole; Mechanical Problem; Nonstandard Device; Material Puncture/Hole
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) VISITED THE HOSPITAL BECAUSE THE PRODUCT DID NOT FUNCTION PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE LEFT CYLINDER HAD A HOLE, SO THE LEFT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23127809 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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