Torosa 450-1325Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932470810), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, TWO TOROSA TESTICULAR DEVICES WERE EXPLANTED FOR AN UNKNOWN REASON. THE ADDITIONAL TOROSA DEVICE IS CAPTURED UNDER A SEPARATE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907291 ↗

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