Rear Tip Extender 72404322Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878953004068), received between Sep 30, 2019 and Mar 10, 2025 — classified as 4 injuries, 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SCROTAL SWELLING AND INFECTION DUE TO AN ABSCESS WITH DRAINAGE ENTIRE INFLATABLE PENILE PROSTHESIS (IPP) REMOVED. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM WITH A TACTRA MALLEABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Abscess; Swelling/ Edema; Unspecified Infection

  MAUDE report 21562182 ↗
• MalfunctionNov 29, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING THE PREPARATION STATE OF AN INFLATABLE PENILE PROSTHESIS IMPLANT SURGERY, THE MEDICAL STAFF IDENTIFIED A HAIR IN THE STERILE PACKAGE OF THESE REAR TIP EXTENDERS (RTES); THEREFORE, A DIFFERENT PACKAGE OF RTES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234810 ↗
• InjuryFeb 17, 2021Disconnection; Migration; Disconnection; Migration

  IT WAS REPORTED THAT AFTER THE FIRST ATTEMPT TO INTRODUCE THE RIGHT INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER THE 2 CM REAR TIP EXTENDER (RTE) GOT STUCK DUE A TIGHT CORPUS CAVERNOSUM, DETACHED ITSELF FROM THE CYLINDER AND MIGRATED TOWARDS THE CRURA OF THE PENIS. THIS COMPLICATED THE PROCEDURE AS IT TOOK AN HOUR AND A HALF MORE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE RTE AND REPLACE IT WITH A 1.5 CM RTE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11340475 ↗
• InjuryJan 15, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO REAR TIP EXTENDERS (RTE'S) BEING OVERSIZED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP REMAINS IMPLANTED AND ACTIVE AND ONLY THE RTE'S WERE EXPLANTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT PRESENTED TO THE PHYSICIAN BUCKLING WHEN INFLATED AND PAIN AND THE PATIENT IS POSITIVE FOLLOWING THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 9592787 ↗
• InjurySep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT EXPERIENCED UNSPECIFIED ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP). ONLY THE IPP REAR TIP EXTENDERS (RTE) WERE USED. IT WAS FURTHER REPORTED THAT THE REASON FOR THIS SURGERY WAS DUE TO THE DISTAL TIP OF THE CYLINDER IN THE LEFT CORPORAL BODY WAS LONGER THEN THE CYLINDER IN THE RIGHT CORPORAL BODY. THE PATIENT DID NOT LIKE THIS DISCREPANCY AND HE WANTED THE CYLINDER EVEN IN THE GLANS. A 2 CM RTE WAS REMOVED FROM THE LEFT CYLINDER AND A .5 CM RTE WAS PLACED BACK IN THE LEFT CYLINDER. THE PATIENT STATUS FOLLOWING THIS SURGERY WAS THAT THERE WAS NO PATIENT ISSUE AND THE IMPLANT WAS FUNCTIONING AS DESIGNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9135422 ↗