Rear Tip Extender 72404323Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00878953004075), received between Nov 20, 2018 and Aug 9, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE REAR TIP EXTENDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WERE REPLACED WITH SMALLER ONES DUE TO POTENTIAL EROSION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 19950077 ↗
• MalfunctionJul 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING THE PREPARATION FOR A PENILE PROSTHESIS PROCEDURE, A FOREIGN MATERIAL INSIDE THE STERILE PACKAGING OF THE REAR TIP EXTENDERS (RTES) WAS DETECTED; THEREFORE, THOSE RTES WERE NOT UTILIZED. OTHER RTES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302191 ↗
• InjuryFeb 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY DUE TO DISCOMFORT IN THE SCROTUM. UPON EXPLORATION, THE PHYSICIAN DETERMINED THAT THE PATIENT NEEDED SHORTER REAR TIP EXTENDERS (RTES), THEREFORE THE RTES WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 16292501 ↗
• InjuryApr 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY IN WHICH THE RIGHT REAR TIP EXTENDER, WHICH WAS TOO LONG, WAS REMOVED AND REPLACED WITH A SHORTER ONE. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160956 ↗
• MalfunctionMar 29, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED ON (B)(6) 2021 TO HAVE THE INFLATABLE PENILE PROSTHESIS REPLACED AS AFTER 2 YEARS OF IMPLANT. THE DEVICE NEVER SEEMED TO GET TO 100% HARDNESS AND SEEMED TO HAVE LOST SOME LENGTH AND GIRTH. THE ENTIRE PUMP MECHANISM DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585246 ↗
• InjuryMay 4, 2020Collapse; Inflation Problem; Mechanical Problem; Collapse; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO MALFUNCTION AS THE DEVICE FAILED TO ERECT PROPERLY. NO AIR OR HOLES WERE OBSERVED, BUT THE PUMP BULB STAYED FLAT. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED, THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE AND THE EVENT RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10022443 ↗
• InjuryFeb 5, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS REAR TIP EXTENDERS (RTE) REMOVED DUE TO A POTENTIAL CROSSOVER LEADING TO A DECREASE IN POTENTIAL GIRTH. DURING THE REVISION SURGERY THE PHYSICIAN FELT THERE WAS NO CROSSOVER AND DOWNSIZED THE RTE TO A TOTAL LENGTH OF 2.5 CM RATHER THAN THE PREVIOUS 3.0 CM INDICATING A SLIGHT BUCKLE WITH THE OLD 3.0 RTE. THE NEW RTE WERE PUT IN AND DESIRED RESULT WAS ACHIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8307488 ↗
• InjuryNov 20, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REPLACEMENT SURGERY DUE TO AN UNSPECIFIED REASON. THE PREVIOUS 3.0 CM RTE WAS REMOVED, AND REPLACED WITH 5.0CM RTE. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE 3.0 CM RTE WAS REPLACED WITH THE 5.0 CM RTE BECAUSE THE IMPLANT APPEARED TOO SHORT. NO PATIENT COMPLICATIONS WERE REPORTED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089878 ↗