Torosa 450-1329Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05708932470858), received between Mar 1, 2016 and Jun 25, 2026 — classified as 17 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Migration

  ACCORDING TO THE AVAILABLE INFORMATION, TOROSA REMOVED AND REPLACED DUE TO RIDING HIGH IN THE SCROTUM. THE IMPLANT MIGRATED OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621179 ↗
• MalfunctionAug 27, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, DURING IMPLANTATION SURGERY IT WAS IDENTIFIED THAT THE IMPLANT HAD A HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907070 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS REPLACED DUE TO INFECTION AND PATIENT PREFERENCE AS THE POSITIONING WAS UNCOMFORTABLE.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 22136371 ↗
• MalfunctionMar 11, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE SITE OPENED UP THE IMPLANT, THEY SAW IT HAD A HOLE IN IT BEFORE IT WAS USED. THEY OPENED ANOTHER IMPLANT TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572466 ↗
• MalfunctionDec 23, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE AVAILABLE INFORMATION, AFTER PREPPING THE DEVICE, THE DEVICE WAS PLACED AND AN INITIAL IN SITU ASSESSMENT FOR FIT AND FEEL WAS PERFORMED. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, AND AT THIS POINT THE PHYSICIAN NOTICED A SMALL PINHOLE DEFECT IN THE SIDE OF THE IMPLANT. THE HOLE WAS ROUGHLY 1/3RD OF THE WAY DOWN THE SIDE OF THE IMPLANT. THE PHYSICIAN BELIEVED, GIVEN THE LOCATION OF THE HOLE, THAT THERE WAS NO WAY HE COULD'VE PUNCTURED THE IMPLANT DURING PREP OR PLACEMENT, AS THE BUTTERFLY NEEDLE TIP DID NOT COME CLOSE TO THE LOCATION OF THE HOLE. A NEW IMPLANT WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21001095 ↗
• MalfunctionDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION, DURING PREPARATION OF A TESTICULAR IMPLANT, THE DEVICE STARTED LEAKING AND WAS THEREFORE NOT IMPLANTED. THE PATIENT WAS THEN IMPLANTED WITH A DIFFERENT IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832456 ↗
• InjurySep 20, 2024Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  ACCORDING TO THE AVAILABLE INFORMATION, THE IMPLANT WAS REMOVED AND REPLACED DUE TO PATIENT PREFERENCE AND IMPLANT SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267205 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT EXPERIENCED SCROTAL SWELLING 2 WEEKS POST IMPLANT. THE CT SHOWED THERE WAS AN 11 CM FLUID COLLECTION IN THE RIGHT HEMISCROTUM. THE PHYSICIAN ENDED UP REMOVING THE TESTICULAR IMPLANT DUE TO THE PATIENT DEVELOPING A FEVER. IT WAS NOTED THE HEMATOMA ENDED UP BEING INFECTED.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 19448988 ↗
• InjuryMar 18, 2024Migration; Migration

  ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PATIENT PREFERENCE. THE PATIENT FELT THAT THE IMPLANT WAS POSITIONED TOO HIGH INSIDE THE SCROTUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18925112 ↗
• MalfunctionNov 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE AVAILABLE INFORMATION WHEN THE TESTICULAR IMPLANT WAS INSERTED IN A PATIENT IT STARTED LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084711 ↗
• InjuryJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO FLUID LOSS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087839 ↗
• InjuryJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO FLUID LOSS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087825 ↗
• MalfunctionMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A LEAK. WHEN THE PACKAGE WAS OPENED, THE DEVICE WAS LEAKING. IT WAS NOTED THERE WAS NO DAMAGE TO THE PACKAGING DURING SHIPPING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872879 ↗
• MalfunctionAug 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED REPLACEMENT DUE TO FOREIGN MATERIAL IN THE PACKAGING. A HAIR WAS FOUND IN THE PACKAGE AFTER IT WAS OPENED. THE DEVICE WAS NOT USED ON THE PATIENT AND INSTEAD A NEW DEVICE WAS USED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182715 ↗
• InjurySep 23, 2021Break; Positioning Problem; Break; Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION THE SALINE TESTICULAR DEVICE WAS IMPLANTED AND REPLACED ON (B)(6) 2021 DUE TO THE SUTURE TAB BROKE. THE PATIENT RECEIVED THE INITIAL IMPLANT, FILLED PROPERLY. THE PATIENT COMPLAINED, "TOO HARD, WRONG POSITION". ADDITIONAL INFORMATION RECEIVED FROM THE TERRITORY MANAGER NOTED THAT IN THE RECOVERY ROOM, THE PATIENT COMPLAINED ABOUT THE TOROSA BEING TOO HARD AND DIDN¿T LIKE THE WAY THAT IT FELT. THE IMPLANT WAS FILLED PER RECOMMENDED FILL VOLUMES. THE TOROSA WAS SUTURED IN PLACE. FROM WHAT THE DOCTOR DESCRIBED THE PATIENT SAID IT DIDN¿T QUITE FEEL RIGHT. THE DOCTOR COULDN¿T DETECT ANYTHING OUT OF THE ORDINARY, BUT THE PATIENT WAS PERSISTENT SO HE DECIDED TO TAKE THE PATIENT BACK TO THE OR JUST AN HOUR OR SO LATER (SINCE THE PATIENT WAS STILL AT THE HOSPITAL IN RECOVERY). UPON OPENING THE SAME INCISION, IT WAS DISCOVERED THAT THE SUTURE TAB WAS TORN. THE DOCTOR QUESTIONED IF HE TIED THE SUTURE TOO TIGHT AROUND THE TAB TO CAUSE THE TEAR BUT IT WAS NOT CLEAR WHAT CAUSED THE TEAR. A SECOND TOROSA WAS PREPPED AND REPLACED, SUTURING IT INTO PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520532 ↗
• InjuryDec 12, 2020Positioning Problem; Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, REPORTED COMPLAINT: "PATIENT COMPLAINS OF THE PAINFULNESS. THE DEVICE IS ALSO PUT IN TOO HIGH POSITION". REVISION STATED TO OCCUR ON (B)(6) 2020. THE LOT # WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED.

  Patient problems: Pain

  MAUDE report 10995677 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE ADDITIONAL EVENT INFORMATION RECEIVED FOR RECORD#: (B)(4). ACCORDING TO THE AVAILABLE INFORMATION THE INFLATABLE PENILE PROSTHESIS WAS REMOVED / REPLACED ON (B)(6) 2020 DUE TO PAIN. ADDITIONAL INFORMATION RECEIVED FROM THE TERRITORY MANAGER INDICATED: ¿SUTURE HURTING PATIENT (STABBING PAIN). PROSTHESIS REPLACED. EXPLANTED PROSTHESIS DISCARDED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION AS IT WAS DISCARDED. AS EXAMINATION OF THE DEVICE MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PAIN QUALITY ACCEPTS THE PHYSICIAN¿S OBSERVATIONS AS TO THE REASON FOR SURGICAL INTERVENTION. AS NO LOT# WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS COULD NOT BE COMPLETED.

  Patient problems: Pain

  MAUDE report 10495988 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, ERODED. THE SURGICAL WOUND HAD DEHISCENCE EXPOSING THE TOROSA IMPLANT. THE DEVICE WAS REMOVED. ANOTHER IMPLANT WILL BE PLACED AT A LATER DATE.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 10323471 ↗
• MalfunctionJul 15, 2020Material Deformation; Device Handling Problem; Material Deformation; Device Handling Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT PRESENTED TO THE OR WITH TWO "DEFLATED" TESTICULAR IMPLANTS, OF THE SAME LOT NUMBER. THE PHYSICIAN EXTENDED AT THE ORIGINAL IMPLANTING OFFICE STATED THAT THE ORIGINAL IMPLANTS, WHEN PLACED, WERE NOT FILLED AT TIME OF SURGERY. THE EXPLANTED DEVICES WERE FILLED AFTER CASE - NO LEAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277179 ↗
• MalfunctionApr 1, 2020Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  ACCORDING TO THE AVAILABLE INFORMATION, THE DATE OF IMPLANT WAS NOT PROVIDED BUT OCCURRED APPROXIMATELY ONE MONTH PRIOR TO EXPLANT. THE PATIENT EXPERIENCED FLUID LOSS ONE WEEK PRIOR TO EXPLANT. PRIOR TO THE FLUID LOSS THE PATIENTS CHIEF COMPLAINT WAS THE AESTHETIC, UPON HEALING. THE IMPLANT DEFLATED INTERNALLY AND UPON EXPLANT IT WAS NOTED THERE WAS NO SALINE IN THE IMPLANT.

  Patient problems: No Information

  MAUDE report 9910570 ↗
• InjuryDec 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE AVAILABLE INFORMATION, MONTHS AFTER THE IMPLANT OF THE DEVICE, THE PATIENT NOTICED THE IMPLANT HAD DEFLATED (THE EVENT WAS OBSERVED IN SEPTEMBER 2019). ANOTHER TOROSA WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 9497735 ↗
• InjuryJan 15, 2019Deflation Problem; Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT HAD TO RETURN DUE TO A FLAT IMPLANT DONE ABOUT A MONTH PRIOR. THE OLD IMPLANT WAS REMOVED AND WAS COMPLETELY FLAT WITH NO FLUID. UPON FILLING IT TO CHECK FOR LEAKS, NONE WERE IDENTIFIED. A NEW IMPLANT WAS PLACED.

  Patient problems: No Information

  MAUDE report 8248320 ↗
• InjuryOct 11, 2018Deflation Problem; Deflation Problem

  ACCORDING TO THE AVAILABLE INFORMATION, TOROSA BECAME DEFLATED. NO HOLES COULD BE IDENTIFIED UPON EXPLANT.

  Patient problems: No Information

  MAUDE report 7957574 ↗
• InjurySep 21, 2017Leak/Splash; Defective Device; Device Markings/Labelling Problem

  ACCORDING TO THE AVAILABLE INFORMATION, ON EXAMINATION OF THE IMPLANT, THE SURGEON NOTICED A MARK ON FILLING THE IMPLANT. THE PROSTHESIS STARTED TO LEAK AT THIS DEFECTIVE MARK. ADDITIONAL INFORMATION RECEIVED 08/31/2017: PROCEDURE NOT COMPLETED SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 6883814 ↗
• MalfunctionNov 29, 2016Device Operates Differently Than Expected

  MALFUNCTION OF TESTICULAR IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 6132965 ↗

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