AMS 700 CXR MS Pump 72404266Recalls & reported problems
Boston Scientific Corporation · Inflatable Penile Prosthesis, Preconnect Infrapubic, 1 Pump to 2 Cylinders · Class 3 · Implant
All models of AMS 700 CXR MS Pump (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00878953003740), received between Oct 17, 2018 and Sep 11, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (3 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, 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
- Mechanical Problem3
- Inadequacy of Device Shape and/or Size2
- Air/Gas in Device1
- Defective Device1
- Degraded1
- Material Puncture/Hole1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Discomfort1
- No Known Impact Or Consequence To Patient1
- Perforation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryDec 10, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT SATISFIED WITH THE LENGTH OF THE IMPLANT, IT DID NOT REACH THE GLANS. THE IPP WAS REMOVED AND REPLACED WITH LONGER CYLINDERS. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892943 ↗InjurySep 11, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REMOVE THE CYLINDER AND RESERVOIR OF AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE PUMP NOT BEING ABLE TO BE USED. THE CYLINDER WAS INFLATED AND A DEACTIVATION KIT WAS USED TO MAKE THE DEVICE A TACTRA DEVICE. THE PATIENT IS EXPECTED TO FULLY RECOVER FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20196190 ↗InjuryMar 11, 2021Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO CYLINDER ANEURYSM. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11464140 ↗InjuryApr 11, 2019Defective Device; Defective Device
IT WAS REPORTED THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY DUE TO AN UNSPECIFIED MALFUNCTION. THE EXISTING CYLINDERS AND PUMP COMPONENTS WERE EXPLANTED AND REPLACED WITH NEW COMPONENTS. THE EXISTING RESERVOIR REMAINS IMPLANTED IN THE PATIENT. THE EXPLANTED COMPONENTS ARE NOT EXPECTED TO BE RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, OR PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE PRODUCT ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8505578 ↗InjuryOct 17, 2018Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAD AN INFLATABLE PENILE PROSTHESIS EXPLANTED AND REPLACED WITH A 14CMX9.5MM DUE TO THE CYLINDERS CROSSED OVER MID SHAFT AND THE RIGHT CYLINDER WAS CROSSED OVER INTO THE LEFT CORPORA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: Perforation
MAUDE report 7974488 ↗
Other Prosthesis, Penis, Inflatable devices
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- 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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