AMS 700 CXR MS PumpRecalls & reported problems across all models
Boston Scientific Corporation · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 228
- Deaths reported
- 0
- Injuries reported
- 212
- Recalls
- 0
We found 8 models of AMS 700 CXR MS Pump by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 228 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2018 and Sep 28, 2026 — classified as 212 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (64 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 CXR MS Pump problems
Device problems
- Adverse Event Without Identified Device or Use Problem67
- Mechanical Problem64
- Fluid/Blood Leak59
- Inflation Problem53
- Material Puncture/Hole37
- Migration18
- Inadequacy of Device Shape and/or Size17
- Insufficient Device Problem Information15
Patient problems
- No Clinical Signs, Symptoms or Conditions119
- Erosion29
- Unspecified Infection24
- No Known Impact Or Consequence To Patient23
- Pain17
- No Consequences Or Impact To Patient7
- Unspecified Tissue Injury7
- Discomfort6
AMS 700 CXR MS Pump models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMS 700 CXR MS Pump 72404263Prosthesis, Penis, Inflatable98 reports
- AMS 700 CXR MS Pump 72404262Prosthesis, Penis, Inflatable51 reports
- AMS 700 CXR MS Pump 72404261Prosthesis, Penis, Inflatable22 reports
- AMS 700 CXR MS Pump 72404268Prosthesis, Penis, Inflatable21 reports
- AMS 700 CXR MS Pump 72404267Prosthesis, Penis, Inflatable17 reports
- AMS 700 CXR MS Pump 72404264Prosthesis, Penis, Inflatable11 reports
- AMS 700 CXR MS Pump 72404266Prosthesis, Penis, Inflatable7 reports
- AMS 700 CXR MS Pump 72404269Prosthesis, Penis, Inflatable1 report
Recent AMS 700 CXR 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 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50915304 ↗InjurySep 25, 2026Deflation Problem
It was reported that this Inflatable Penile Prosthesis (IPP) was not deflating. Upon inspection, scarring and corporal damage were noticed. As a result, the device was explanted. No patient complications were reported.
Patient problems: Scar Tissue; Unspecified Tissue Injury
MAUDE report 50893081 ↗InjurySep 11, 2026Mechanical Problem; Material Puncture/Hole; Air/Gas in Device
It was reported that the pump of an Inflatable Penile Prosthesis (IPP) stopped working, and air was observed during a computed tomography (CT) scan. A surgical procedure was performed, during which a crack in tubing was observed. As a result, the IPP was removed and replaced. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725311 ↗InjurySep 7, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50651235 ↗InjurySep 1, 2026Collapse; Fluid/Blood Leak; Inflation Problem; Air/Gas in Device
Patient problems: Unspecified Tissue Injury
MAUDE report 50553505 ↗InjuryJul 30, 2026Human-Device Interface Problem
It was reported that the patient implanted with an Inflatable Penile Prosthesis (IPP) experienced scrotal pain when operating the Momentary Squeeze (MS) pump. A surgical procedure was performed, during which no device issue was identified. Although the pump continued to inflate the IPP as intended, its use caused significant pain to the patient. The physician noted difficulty when manipulating the MS pump and elected to replace it with a Tenacio pump. The new pump was implanted in a different scrotal pocket. In addition, a capsule believed to be contributing to the patient's pain was excised. No additional patient complications were reported.
Patient problems: Capsular Contracture; Pain
MAUDE report 50087091 ↗InjuryJul 20, 2026Fluid/Blood Leak; Mechanical 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 IT WAS IDENTIFIED THAT THE TUBING HAD FRACTURED ABOVE THE PUMP CAUSING FLUID LOSS. THE CYLINDERS AND PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25876904 ↗InjuryJul 14, 2026Nonstandard Device
THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND A NON-CONFORMANCE WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25820434 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION IN THE RIGHT CYLINDER THROUGH THE GLANDS, WITH SOME CENTIMETERS OF THE CYLINDER VISIBLE EXTERNALLY. AS A RESULT, THE RIGHT CYLINDER WAS EXPLANTED, AND THE TUBING WAS DEACTIVATED TO ALLOW THE LEFT CYLINDER TO CONTINUE FUNCTIONING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Erosion
MAUDE report 25673519 ↗InjuryJun 29, 2026Inflation Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED INFLATION DIFFICULTIES DURING PUMPING. A SURGICAL INTERVENTION WAS PERFORMED, DURING WHICH A SURROGATE RESERVOIR TEST WAS CONDUCTED. BACK PRESSURE WAS OBSERVED IN THE SURROGATE SYRINGE DURING PUMPING, WITH NO FLUID TRANSFER THROUGH THE PUMP, INDICATING A SUSPECTED PUMP ISSUE. THE PUMP WAS RESET; HOWEVER, NO IMPROVEMENT WAS NOTED. THE RESERVOIR WAS INSPECTED AND CONFIRMED TO STILL CONTAIN FLUID. THE CYLINDERS AND REAR TIP EXTENDERS (RTES) WERE EXPLANTED. NEW CX CYLINDERS AND RTES WERE IMPLANTED AND CONNECTED TO THE EXISTING RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25661237 ↗InjuryJun 1, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) STATED THAT THE DEVICE WAS NOT FUNCTIONING AS WELL AS EXPECTED AND WAS CAUSING DISCOMFORT IN THE PENIS. UPON EXAMINATION, IT WAS DETERMINED THAT THE DEVICE WAS NOT THE APPROPRIATE SIZE, AS IT WAS NOT POSITIONED WITHIN THE GLANS AT THE MEATUS. AS A RESULT, THE CYLINDERS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Discomfort
MAUDE report 25353405 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED CYLINDER EROSION THROUGH THE URETHRA. A SURGICAL INTERVENTION WAS PERFORMED, DURING WHICH NO DEVICE RELATED ISSUES WERE IDENTIFIED. THE IPP WAS EXPLANTED AND FULLY REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Erosion
MAUDE report 25232705 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE POSTOPERATIVE PERIOD FOLLOWING THE IMPLANTATION OF AN INFLATABLE PENILE PROSTHESIS (IPP), THE PATIENT DEVELOPED A HEMATOMA AROUND THE SCROTAL WOUND. HE WAS TREATED WITH ANTIBIOTICS, WHICH RESULTED IN CLINICAL IMPROVEMENT. HOWEVER, DURING SUBSEQUENT FOLLOW UP, THE DEVICE COULD NOT BE ACTIVATED, AS THE PATIENT EXPERIENCED PAIN WHEN ATTEMPTING TO OPERATE THE PUMP. UPON EVALUATION, EXTRUSION OF THE CONNECTION TUBING WAS OBSERVED. IT WAS MENTIONED THAT THE PROBABLE CAUSE, WAS THE HEMATOMA DEVELOPED DURING THE LATE POSTOPERATIVE PERIOD. CONSEQUENTLY, THE PATIENT WAS HOSPITALIZED TO SCHEDULE AN EXPLANT SURGICAL PROCEDURE.
Patient problems: Erosion; Hematoma; Pain
MAUDE report 24802245 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISTAL URETHRAL EROSION ASSOCIATED WITH THE RIGHT CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDERS AND PUMP WERE EXPLANTED AND REPLACED, WHILE THE RESERVOIR WAS RETAINED. THE EROSION SITE WAS REPAIRED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Erosion
MAUDE report 24698465 ↗InjuryMar 4, 2026Fluid/Blood Leak; Mechanical Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AND EXHIBITED FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE CYLINDERS AND PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512545 ↗
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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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