Torosa 450-1327Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05708932470834), received between Sep 4, 2015 and Feb 10, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION THE CUSTOMER REQUESTED TO REMOVE THE DAMAGED DEVICE. THE LEFT SCROTUM WAS SHRUNKEN; PALPATION REVEALED A HARD, DEFORMED OBJECT INSIDE THE SCROTUM. AN INCISION WAS MADE ALONG THE ANTERIOR MIDLINE OF THE LEFT SCROTUM, APPROXIMATELY 3 CM IN LENGTH. DISSECTION WAS CARRIED THROUGH THE SKIN AND MUSCLE LAYERS INTO THE LEFT TUNICA VAGINALIS CAVITY. A LARGE AMOUNT OF CLEAR YELLOW FLUID WAS OBSERVED. ONE SILICONE OBJECT, SOFT AND PLIABLE, RESEMBLING A COMPRESSED ARTIFICIAL TESTICLE, WAS REMOVED FROM THE LEFT TUNICA VAGINALIS. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A POSSIBLE LEAK THROUGH A NEEDLE PUNCTURE SITE AFTER FILLING.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24304165 ↗
• 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 22907517 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, PRIOR TO PATIENT USE / PATIENT CONTACT, THE IMPLANT LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909739 ↗
• MalfunctionNov 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD A TOROSA IMPLANTED ON (B)(6) 2024. DURING THE SURGERY, A MEDIUM-SIZED IMPLANT WAS PLACED. THE PATIENT IS EXPERIENCING BOTH PHYSICAL DISCOMFORT AND CONCERN REGARDING PRODUCT COMPLIANCE. THE SURGERY REPORT THE PATIENT RECEIVED INDICATES THAT THE IMPLANT WAS FILLED WITH 16CC'S OF SALINE BUT THE PATIENT BELIEVES THE MAXIMUM RECOMMENDED FILL LIMIT FOR A MEDIUM IMPLANT DOES NOT EXCEED 15CC'S. CURRENTLY, THE IMPLANT IS RIGID, ABNORMALLY HEAVY, AND THREE TIMES THE SIZE OF THE PATIENT'S REMAINING TESTICLE, CAUSING SUBSTANTIAL PHYSICAL AND PSYCHOLOGICAL DISTRESS. IN FOLLOW-UP WITH THE DOCTOR, THE PATIENT WAS ADVISED ONLY 4 CC'S HAD BEEN USED. A PHOTO OF THE SURGERY REPORT REFERENCED BY THE PATIENT SHOWS THE IMPLANT STICKER WHICH REFERENCES 16CC FOR A MEDIUM TOROSA.

  Patient problems: Discomfort

  MAUDE report 20622446 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18685748 ↗
• InjuryApr 27, 2023Unintended Deflation; Unintended Deflation

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRES REPLACEMENT DUE TO DEFLATION. THE SURGERY WILL BE SCHEDULED FOR A FUTURE DATE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824135 ↗
• MalfunctionFeb 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO MISLABELING. THE DEVICE WAS NEVER IMPLANTED IN THE PATIENT. UPON COMPARING THE SIZER PICTURED NEXT TO THE FILLED MEDIUM SIZED DEVICE, THE SURGEON BELIEVED THAT THE MEDIUM SIZED DEVICE WAS ACTUALLY A SMALL SIZED DEVICE AND POTENTIALLY MISLABELED AS MEDIUM. ANOTHER DEVICE WAS OPENED AND IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435835 ↗
• InjuryJan 9, 2020Material Deformation; Material Deformation

  ACCORDING TO THE AVAILABLE INFORMATION, RIGHT SCROTAL TESTICULAR IMPLANT ONLY LASTED 5 WEEKS BEFORE PARTIALLY DEFLATING. ANOTHER TESTICULAR DEVICE WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 9571966 ↗
• InjurySep 24, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT COLLAPSED, THERE WAS NO SALINE IN THE IMPLANT.

  Patient problems: No Information

  MAUDE report 7904272 ↗
• InjuryMay 9, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  ACCORDING TO THE AVAILABLE INFORMATION, IMPLANT WAS MIGRATING, HAD BEEN TIED DOWN AT SURGERY AND ONCE INCISION WAS MADE, IMPLANT SURFACE. THE TIED DOWN TAB WAS BROKEN.

  Patient problems: No Information

  MAUDE report 7500406 ↗
• MalfunctionAug 12, 2016Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT UNDERWENT REMOVAL OF HIS LEFT TESTICLE DUE TO LEFT TESTICULAR TUMOR. THE PATIENT HAD A PROSTHESIS PLACED AT THE TIME OF REMOVAL. SURGEON WAS NOTIFIED POSTOPERATIVELY THAT THE IMPLANTED PROSTHESIS HAD FAILED AND HAD DEFLATED.

  Patient problems: Failure of Implant

  MAUDE report 5873230 ↗
• InjurySep 4, 2015Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WAS IMPLANTED WITH A TOROSA SALINE FILLED TESTICULAR PROSTHESIS. LATER THE PATIENT EXPERIENCED SCROTAL PAIN AND IRRITATION AND THE IMPLANT WAS REMOVED.

  Patient problems: Irritation; Pain

  MAUDE report 5058024 ↗

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