Torosa 450-1323Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05708932470797), received between May 7, 2025 and Jan 27, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (P020003); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION IN MEDSUN REPORT # 0700220000-2025-8438: TWO EXTRA SMALL TOROSA TESTICULAR PROSTHESIS WERE OPENED FOR USE. THEY BOTH HAD PIN HOLES IN THEM IN THE SAME SPOT AND THEY WERE FROM THE SAME BATCH. NEITHER WERE ABLE TO BE USED IN PATIENT AND THERE WERE NO MORE EXTRA SMALLS IN STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190237 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, A LEAK WAS NOTICED FROM A SMALL HOLE DURING THE FILLING OF THE PROSTHESIS WITH SALINE. AS A RESULT, THE PROSTHESIS WAS NEVER INTRODUCED INTO THE PATIENT. A NEW TESTICULAR PROSTHESIS WAS OPENED AND PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709805 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS LEAKING WHEN FILLING THE IMPLANT DURING THE INITIAL IMPLANT PROCEDURE. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593651 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, DURING PREPARATION, THERE WAS A FLUID LEAK NOTED. THE DEVICE WAS NOT INSERTED OR IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980558 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020003. One submission often covers many models, so check the product and lot details in each record.

• Z-0820-2011 · Apr 30, 2010 · Terminated
  Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 5