AMS 700 CX MS Pump 72404286Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis, Preconnect Infrapubic, 1 Pump to 2 Cylinders · Class 3 · Implant
All models of AMS 700 CX MS Pump (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953003894), received between Feb 17, 2026 and May 27, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Inadequacy of Device Shape and/or Size1
- Inflation Problem1
- Mechanical Problem1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Fluid/Blood Leak; Inflation Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING COMPLETELY AND WAS ASSOCIATED WITH FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH ALL COMPONENTS WERE EXPLANTED AND REPLACED, EXCEPT FOR THE RESERVOIR, WHICH WAS RETAINED. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303083 ↗InjuryFeb 17, 2026Mechanical Problem; Inadequacy of Device Shape and/or Size; Migration
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH ASYMMETRY, AS ONE SIDE APPEARED LONGER THAN THE OTHER, AND THE DEVICE DID NOT SEEM TO FUNCTION CORRECTLY. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE PHYSICIAN SUSPECTED A POSSIBLE PROXIMAL EROSION ON THE LEFT SIDE AND A CROSSOVER; HOWEVER, NO EROSION WAS CONFIRMED. DURING SURGERY, THE CROSSED OVER CYLINDER WAS EXPLANTED, THE AFFECTED CORPORAL SPACE WAS REMEASURED, AND IT WAS DETERMINED THAT A LONGER REAR TIP EXTENDER WAS REQUIRED. A 2 CM RTE WAS REPLACED WITH A 4CM RTE TO MATCH THE RIGHT SIDE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Tissue Injury
MAUDE report 24370294 ↗
Other Prosthesis, Penis, Inflatable devices
- AMS 700 MS Pump 72404310Boston Scientific Corporation · Prosthesis, Penis, Inflatable992 reports
- AMS 700 LGX MS Pump 72404252Boston Scientific Corporation · Prosthesis, Penis, Inflatable1 death757 reports
- AMS 700 CX MS Pump 72404233-12Boston Scientific Corporation · Prosthesis, Penis, Inflatable656 reports
- AMS 700 CX MS Pump 72404232Boston Scientific Corporation · Prosthesis, Penis, Inflatable639 reports
- AMS 700 LGX MS Pump 72404251Boston Scientific Corporation · Prosthesis, Penis, Inflatable611 reports
- Conceal 720185-01Boston Scientific Corporation · Prosthesis, Penis, Inflatable586 reports
- AMS 700 LGX MS Pump 72404252-10Boston Scientific Corporation · Prosthesis, Penis, Inflatable561 reports
- AMS 700 CX MS Pump 72404232-10Boston Scientific Corporation · Prosthesis, Penis, Inflatable533 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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