TorosaRecalls & reported problems across all models
Coloplast A/S · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 0
We found 4 models of Torosa by Coloplast A/S in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2015 and Jun 25, 2026 — classified as 26 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Torosa problems
Device problems
- Fluid/Blood Leak10
- Adverse Event Without Identified Device or Use Problem6
- Material Puncture/Hole5
- Deflation Problem4
- Leak/Splash4
- Insufficient Device Problem Information3
- Break2
- Device Markings/Labelling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Information8
- Failure of Implant3
- Pain3
- Unspecified Infection3
- Discomfort2
- Wound Dehiscence2
- Deformity/ Disfigurement1
Torosa models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Torosa 450-1329Prosthesis, Testicular28 reports
- Torosa 450-1327Prosthesis, Testicular12 reports
- Torosa 450-1323Prosthesis, Testicular4 reports
- Torosa 450-1325Prosthesis, Testicular1 report
Recent Torosa adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Coloplast A/S products
All Coloplast A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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