AMS 700 CX MS Pump 72404283-12Recalls & reported problems
Boston Scientific Corporation · AMS 700 Inflatable Penile Prosthesis, Preconnected 1 MS Pump to 2 CX Cylinders with 12 cm long preconnect tubing length, Penoscrotal · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878953009841), received between Sep 4, 2024 and Aug 22, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Deflation Problem1
- Mechanical Problem1
- Migration1
Patient problems
- Unspecified Infection2
- Discomfort1
- Erosion1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED HERNIATION OF THE DEVICE, WHICH WAS SUBSEQUENTLY CONFIRMED BY MAGNETIC RESONANCE IMAGING (MRI). THE PROSTHESIS REMAINS IMPLANTED, AND SURGICAL INTERVENTION IS PLANNED. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.
Patient problems: Erosion
MAUDE report 22874474 ↗InjuryMar 27, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCE DISCOMFORT AND SUBACUTE INFECTION. THE DEVICE WAS HARD TO PUMP. THE PATIENT UNDERWENT CLINICAL TREATMENT WITH EXTENDED INTRAVENOUS ANTIBIOTIC THERAPY AND WAS ADMITTED TO HOSPITAL. THE IPP WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 21707006 ↗InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL PAIN AND INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY, DURING WHICH THE PUMP WAS REMOVED, A WASHOUT WAS PERFORMED, AND A NEW PUMP WAS IMPLANTED. THERE WERE NO DEVICE ISSUES AND NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 20471478 ↗MalfunctionSep 4, 2024Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING PREPARATION FOR THE IMPLANT PROCEDURE OF AN INFLATABLE PENILE PROSTHESIS, WHEN PRESSING THE PUMP DEFLATION BUTTON, AIR WOULD NOT RELEASE FROM THE CYLINDERS. THE TECHNICIAN ATTEMPTED TO DEFLATE BY SQUEEZING THE SIDES OF THE PUMP BLOCK TO MANIPULATE THE DEFLATION VALVE, HOLDING THE DEFLATING BUTTON, RELEASING AND SQUEEZING THE PUMP, ALTERNATING BACK AND FORTH. HOWEVER, THE ISSUE PERSISTED. THE CYLINDERS WERE FILLED WITH SALINE AND FLUID WOULD NOT RELEASE AFTER PRESSING THE DEFLATION BUTTON. THE PHYSICIAN SQUEEZED THE IMPLANT AS HARD AS HE COULD AND THE IMPLANT FINALLY DEFLATED. WHEN INFLATED AGAIN, THE DEFLATION ISSUE PERSISTED. THEREFORE, ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20136051 ↗
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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