AMS 700 CXR RTE Kit 72404043Recalls & reported problems
Boston Scientific Corporation · Rear Tip Extenders for AMS 700 CXR Cylinders, 2 each of Non-Stackable 4, 5, 6 cm RTEs · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878953002774), received between Jun 11, 2019 and Jun 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT IS REPORTED THAT DURING AN INFLATABLE PENILE PROSTHESIS IMPLANT, THE PHYSICIAN FELT THAT THE DEVICE WAS NOT APPLICABLE, THEN REPLACED WITH A SMALL ONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE EVENT RESOLVED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THIS WAS AN ORIGINAL IMPLANT SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8686415 ↗
Other Prosthesis, Penis, Inflatable devices
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- 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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