Rear Tip Extender 72404321Recalls & reported problems
Boston Scientific Corporation · Non-Stackable Rear Tip Extenders for AMS 700 CX and LGX Cylinders · Class 3 · Implant
All models of Rear Tip Extender (6)
Data updated Oct 16, 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 00878953004051), received between Dec 29, 2019 and Feb 21, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THAT WAS NOT POSITIONED TO REACH THE CORONAL GROVE OF THE PENIS. THE PATIENT EXPERIENCED THE TIP OF THE PENIS DROOPING AND COLLAPSING WHEN THE DEVICE WAS FULLY INFLATED. THE IPP REAR TIP EXTENDERS WERE REPLACED, AND THE PHYSICIAN SUSPECTED THAT THE ORIGINAL IMPLANT WAS MEASURED TOO SHORT WHEN IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18749888 ↗MalfunctionDec 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN BODY MATERIAL FOUND INSIDE THE BLISTER PACKAGE. THE MATERIAL WAS OPENED DURING DOCTOR'S REVISION SURGERY. ONE OF THE 1 CM EXTENDERS PRESENT IN THE BLISTER WAS IRRIGATED WITH ANTIBIOTIC AND IMPLANTED IN THE PATIENT. THE PHYSICIAN DID NOT KNOW WHAT THE FOREIGN MATERIAL WAS AS WHEN THE PACKAGE WAS OPENED THE FOREIGN MATERIAL WAS THERE .THE FOREIGN MATERIAL WAS IDENTIFIED WHEN THE PACKAGE WAS OPENED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9528585 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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