AMS 700 LGX MS PumpRecalls & reported problems across all models
Boston Scientific Corporation · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,057
- Deaths reported
- 1
- Injuries reported
- 2,698
- Recalls
- 0
We found 18 models of AMS 700 LGX MS Pump by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 3,057 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2017 and Sep 30, 2026 — classified as 1 death, 2,698 injuries, 358 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (1,018 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 MS Pump problems
Device problems
- Mechanical Problem1,018
- Inflation Problem1,004
- Fluid/Blood Leak826
- Adverse Event Without Identified Device or Use Problem612
- Material Puncture/Hole540
- Deflation Problem188
- Collapse182
- Migration182
Patient problems
- No Clinical Signs, Symptoms or Conditions1,601
- No Known Impact Or Consequence To Patient413
- Unspecified Infection267
- Pain224
- No Consequences Or Impact To Patient200
- Erosion161
- Discomfort131
- Insufficient Information103
AMS 700 LGX MS Pump models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 700 LGX MS Pump 72404252Prosthesis, Penis, Inflatable1 death757 reports
- AMS 700 LGX MS Pump 72404251Prosthesis, Penis, Inflatable611 reports
- AMS 700 LGX MS Pump 72404252-10Prosthesis, Penis, Inflatable561 reports
- AMS 700 LGX MS Pump 72404257Prosthesis, Penis, Inflatable400 reports
- AMS 700 LGX MS Pump 72404253Prosthesis, Penis, Inflatable174 reports
- AMS 700 LGX MS Pump 72404256Prosthesis, Penis, Inflatable139 reports
- AMS 700 LGX MS Pump 72404253-12Prosthesis, Penis, Inflatable121 reports
- AMS 700 LGX MS Pump 72404258Prosthesis, Penis, Inflatable85 reports
- AMS 700 LGX MS Pump 72404302Prosthesis, Penis, Inflatable67 reports
- AMS 700 LGX MS Pump 72404301Prosthesis, Penis, Inflatable54 reports
- AMS 700 LGX MS Pump 72404250Prosthesis, Penis, Inflatable49 reports
- AMS 700 LGX MS Pump 72404303Prosthesis, Penis, Inflatable13 reports
- AMS 700 LGX MS Pump 72404255Prosthesis, Penis, Inflatable12 reports
- AMS 700 LGX MS Pump 72404300Prosthesis, Penis, Inflatable7 reports
- AMS 700 LGX MS Pump 72404305Prosthesis, Penis, Inflatable2 reports
- AMS 700 LGX MS Pump 72404306Prosthesis, Penis, Inflatable2 reports
- AMS 700 LGX MS Pump 72404307Prosthesis, Penis, Inflatable2 reports
- AMS 700 LGX MS Pump 72404302-10Prosthesis, Penis, Inflatable1 report
Recent AMS 700 LGX MS Pump adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953783 ↗InjurySep 29, 2026Fluid/Blood Leak; Material Puncture/Hole
It was reported that Inflatable Penile Prosthesis (IPP) wasn't working properly due to fluid floss. Upon revision, a fracture in the tubing from pump to reservoir was noticed. As a result, the device was explanted. No further patient complications were replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932539 ↗InjurySep 28, 2026Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926217 ↗InjurySep 28, 2026Inflation Problem; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924225 ↗InjurySep 28, 2026Degraded
It was reported that patient wasn't satisfied with his Inflatable Penile Prosthesis (IPP). As a result, the device was explanted and replaced. A bulge was then noticed in the cylinder. No further patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917389 ↗InjurySep 25, 2026Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Air/Gas in Device
Patient problems: Perforation
MAUDE report 50899777 ↗InjurySep 25, 2026Collapse; Inflation Problem; Material Puncture/Hole
It was reported that this Inflatable Penile Prosthesis (IPP) stopped pumping up and stopped rebounding. A surgical procedure was performed during which the entire device was explanted and replaced with a malleable device. Upon explant the physician observed the right cylinder had a small pinhole. The physician believed the patient may have attempted augmenting themselves post-surgery. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899150 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) developed an infection approximately ten months after implantation. The physician treated the infection with antibiotics. A surgical procedure was performed in which the existing IPP was explanted and replaced with a new Inflatable Penile Prosthesis (IPP). The physician indicated that the infection was attributed to a microbial source and not to foreign material associated with the device. There were no further patient complications reported.
Patient problems: Unspecified Infection
MAUDE report 50885682 ↗InjurySep 23, 2026Collapse; Inflation Problem; Mechanical Problem
It was reported that this Inflatable Penile Prosthesis (IPP) would not inflate properly, as the patient experienced issues with the pump not working well. The pump bulb was reported to stay flat. A surgical procedure was performed in which the existing device was explanted and replaced. There were no patient complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870441 ↗InjurySep 23, 2026Mechanical Problem
It was reported that a patient with an Inflatable Penile Prosthesis (IPP) had a device no longer functioning. A revision procedure was done to explant and replace the device. No further patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867421 ↗InjurySep 21, 2026Inflation Problem; Migration
Patient problems: Unspecified Tissue Injury
MAUDE report 50848830 ↗InjurySep 21, 2026Mechanical Problem; Nonstandard Device; Material Puncture/Hole
It was reported that the patient was unable to cycle the cylinders and presented for revision surgery. During the procedure, the explanted cylinders were observed to have what appeared to be damage to the silicone layer. A replacement surgery was performed, and new cylinders were implanted. No patient complications were reported, and the patient is expected to fully recover.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842884 ↗InjurySep 21, 2026Inflation Problem
It was reported that the patient was having trouble inflating the cylinders and that the cylinders of the Inflatable Penile Prosthesis (IPP) were not rigid enough for sex. As a result, the LGX was replaced for a more rigid CX. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841987 ↗InjurySep 21, 2026Inadequacy of Device Shape and/or Size
It was reported that patient complained of floppy glands. Upon inspection, physician found that tips of the Inflatable Penile Prosthesis (IPP) did not come to the top of the penile gland. As a result, the device was explanted and replaced. No further patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840530 ↗InjurySep 10, 2026Degraded; Material Puncture/Hole; Inadequacy of Device Shape and/or Size
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced pain and discomfort inside the corporal bodies. Upon inspection, wear of the outer layer of the cylinders was identified, resulting in cylinder buckling. A potencial oversizing of the device or a weak point in the patient corporal body were the possible causes of the discomfort. As a result, the cylinders and pump were explanted and replaced. No further patient complications were reported.
Patient problems: Discomfort; Pain
MAUDE report 50714892 ↗
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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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