AMS 700 CXR RTE Kit 72403872Recalls & reported problems
Boston Scientific Corporation · Rear Tip Extenders for AMS 700 CXR Cylinders, 2 each of Non-Stackable 0.5, 1, 2, 3 cm RTEs and Stackable 1.5 cm RTEs · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878953002408), received between Apr 2, 2020 and Aug 31, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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
- Inadequacy of Device Shape and/or Size2
- Inflation Problem1
- Malposition of Device1
- Mechanical Problem1
Patient problems
- Deformity/ Disfigurement1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Inflation Problem; Mechanical Problem; Inadequacy of Device Shape and/or Size; Malposition of Device
It was reported that a patient underwent an Inflatable Penile Prosthesis (IPP) revision surgery because the device was not functioning. No patient complications were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533587 ↗MalfunctionApr 2, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE PHYSICIAN WITHDREW THE EXTENSION BODY(REAR TIP EXTENDER) RTE DUE TO A MEASUREMENT ISSUE. THE DEVICE WAS FOUND THAT THE TWO SIDES WERE NOT THE SAME LENGTH, SO THE PHYSICIAN WITHDREW THE EXTENSION BODY. A PATIENT OUTCOME OF STABLE WAS REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE PHYSICIAN WAS UNABLE TO INSERT THE CYLINDER AT ONE SIDE. A 16CM CYLINDER AND A 1CM RTE REMAIN IMPLANTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED THAT DURING INSTALLATION OF THE RTE, IT WAS FOUND THAT ONE SIDE OF THE PENIS WAS BENT, CAUSING ASYMMETRY BETWEEN THE TWO SIDES. AFTER SEVERAL ATTEMPTS, THE RESULT WAS NOT SATISFACTORY, AND THE PENIS WAS FINALLY REMOVED.
Patient problems: Deformity/ Disfigurement; No Consequences Or Impact To Patient
MAUDE report 9918944 ↗
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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