CoolSeal TrinityRecalls & reported problems across all models

We found 3 models of CoolSeal Trinity by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2021 and Sep 2, 2026 — classified as 1 death, 26 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (4 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

Most reported CoolSeal Trinity problems

CoolSeal Trinity models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CoolSeal™ Trinity CSL-TR105-37

  Electrosurgical, cutting & coagulation & accessories
  28 reports
• CoolSeal™ Trinity CSL-TR105-30

  Electrosurgical, cutting & coagulation & accessories
  1 death6 reports
• CoolSeal™ Trinity CSL-TR105-44

  Electrosurgical, cutting & coagulation & accessories
  5 reports

Recent CoolSeal Trinity adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Failure to Seal

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50575848 ↗
• InjuryAug 26, 2026Failure to Seal

  It was reported that during a CoolSeal Trinity procedure on (b)(6) 2026, the physician reported that during the procedure the device did not seal sufficiently which caused bleeding (Less than 1 ml). The device was exchanged and the procedure was completed without any further issues. No other information available.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50454156 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING A SALPINGO-OOPHORECTOMY USING A COOLSEAL TRINITY, THE PHYSICIAN REPORTED THAT WHILE CUTTING ONE OF THE FALLOPIAN TUBES THE DEVICE CUT BUT DID NOT SEAL AND THE FALLOPIAN TUBE STARTED TO BLEED WITH AN APPROXIMATE BLOOD LOSS OF 50ML. THE TISSUE WAS NOT BLANCHED. AT THIS POINT ANOTHER COOLSEAL TRINITY WAS USED BUT DID NOT PROVIDE A GOOD SEAL TONE. AT THIS POINT A THIRD-PARTY DEVICE (LIGASURE) WAS USED TO COMPLETE THE CASE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25447415 ↗
• InjuryMar 25, 2026Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COOLSEAL TRINITY ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THE DEVICE WAS NOT SEALING SUFFICIENTLY AND CAUSED BLEEDING FROM SMALL VESSELS AND WERE OOZING MORE THAN NORMAL. THE EXACT AMOUNT OF BLOOD COULD NOT BE QUANTIFIED. THE PHYSICIAN DECIDED TO SWITH TO ANOTHER MODALITY OF DEVICE AND WAS ABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED AT THE END OF PROCEDURE. PATIENT WAS DISCHARGED AS NORMAL PROTOCOL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24688283 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COOLSEAL PROCEDURE ON (B)(6) 2025, THE PHYSICIAN WAS PERFORMING A GASTRIC SLEEVE AND WHEN SEALING FATTY TISSUE AROUND A VESSEL THE PHYSICIAN CLAMPED A LARGE VESSEL. THE SEAL BUTTON WAS PRESSED AND THE SYSTEM GAVE A COMPLETE SEAL TONE. AND WHEN THE PHYSICIAN RELEASED THE VESSEL SIGNIFICANT BLEEDING OCCURRED. SURGEON WAS ABLE TO SEAL USING SURGICEL AND SUTURES. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22726240 ↗
• MalfunctionAug 1, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A COOLSEAL PROCEDURE ON (B)(6) 2025, DURING THE MIDDLE OF THE PROCEDURE WHILE PERFORMING A LAPAROSCOPIC DIAPHRAGMATIC HERNIA ON A 1 YEAR OLD, THE STAFF NOTICED A BLACK MATERIAL ON THE ABDOMEN COMING FROM THE DEVICE. THE COOLSEAL WAS CHECKED AND IT WAS NOTICED THAT THE COATING CLOSE TO THE TIP WAS PEELING. THE DEVICE WAS EXCHANGED FOR A NEW DEVICE AND THE PROCEDURE COMPLETED SUCCESSFULLY. MATERIAL WAS OBSERVED INSIDE THE CAVITY AND IT WAS IRRIGATED AND FLUSHED. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22692235 ↗
• DeathApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COOLSEAL TRINITY PROCEDURE ON (B)(6) 2024, A COOLSEAL TRINITY 30CM AND COOLSEAL GENERATOR WERE USED DURING A THORACOSCOPIC PROCEDURE ON A CHILD (6 YEARS OLD, FEMALE), DISSECTING AND SEALING VESSELS. DURING THE PROCEDURE IT WAS IDENTIFIED THAT THE PATIENT WAS BLEEDING FROM A PREVIOUSLY DISSECTED AND SEALED BRANCH OF THE PULMONARY ARTERY, AND THERE WERE CONCERNS OF A POTENTIAL SEAL FAILURE. THE PATIENT SUFFERED SIGNIFICANT BLEEDING WHICH COULD NOT BE STOPPED, RESULTING IN PATIENT DEATH. ON A FOLLOW UP EMAIL IT WAS DETERMINED THAT THE BLEEDING STARTED 3 HOURS AFTER THE SURGERY BEGAN, MAJOR BLEEDING WAS ENCOUNTERED FROM A CORNER OF A PREVIOUSLY SEALED AND DIVIDED BASAL ARTERIAL BRANCH. THE PROCEDURE WAS A VIDEO ASSISTED THORACOSCOPIC LOBECTOMY SURGERY. NO PRE-EXISTENT CONDITIONS WERE REPORTED. MULTIPLE STEPS WERE TAKEN AFTER THE BLEEDING WAS OBSERVED TO TREAT IT, COMPRESSION, TRANEXAMIC ACID AND BLOOD TRANSFUSION. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21886742 ↗
• InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A COOLSEAL PROCEDURE ON (B)(6) 2024 ON A SALPINGECTOMY. THE PATIENT WAS REPORTED TO HAVE AN ACTIVE ABDOMINAL BLEEDING AFTER THE PROCEDURE WHICH REQUIRED TO BE TAKEN TO THE OPERATING ROOM. CAUSE OF BLEEDING IS NOT KNOWN. PATIENT WAS LATER RELEASED FROM THE HOSPITAL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21193017 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COOLSEAL PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT THEY WERE DISSATISFIED WITH THE SEAL QUALITY OF THE DEVICE. PHYSICIAN REPORTED THAT THEY RECEIVED A COMPLETE TONE FASTER THAN USUAL AND WHEN INSPECTING THE SEAL COULD SEE THAT THE SEAL WAS NOT ADEQUATE. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. PHYSICIAN REPORTED THAT HE OBSERVED BLEEDING FROM THE INADEQUATE SEAL THAT HAD TO BE HELD CLOSED BY A GRASPER UNTIL A SECOND DEVICE WAS OPENED. THE PROCEDURE WAS A DUODENAL SWITCH. NO ADDITIONAL PATIENT INJURY OR INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21035510 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A COOLSEAL PROCEDURE IN A CHOLECYSTECTOMY WAS BEING PERFORMED THE PHYSICIAN ATTEMPTED TO CREATED A SEAL ON THE MESENTERY AND SAW BLEEDING. THE PHYSICIAN REPORTED THAT BLEEDING WAS OBSERVED AFTER THE INADEQUATE SEAL AND ANOTHER SEALER WAS USED TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20620159 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A COOLSEAL PROCEDURE IN WHICH MESENTERY WAS BEING CUT THE PHYSICIAN ATTEMPTED TO CREATED A SEAL ON THE MESENTERY AND SAW BLEEDING. THE PHYSICIAN REPORTED THAT BLEEDING WAS OBSERVED AFTER THE INADEQUATE SEAL AND ANOTHER SEALER WAS USED TO COMPLETE THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20620150 ↗
• InjurySep 19, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT DURING A COOLSEAL TRINITY PROCEDURE ON AUGUST 22ND, THE PHYSICIAN REPORTED THAT IT WAS EXPERIENCING A ¨LITTLE BLEEDING ISSUE¨, IT WAS REPORTED THAT HE WENT BACK TO SEAL THREE TIMES AND WAS UNSUCCESSFUL. THE PROCEDURE WAS A MODIFIED DUODENAL SWITCH, PHYSICIAN REPORTED THAT AROUND 12 SEALS HAD TO BE RESEALED. THE DEVICE WAS EXCHANGED, AND NO INJURY WAS REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND DEVICE. THE AMOUNT OF BLEEDING WAS REPORTED AS NOT A HIGH AMOUNT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20262887 ↗
• InjurySep 2, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT ON AUGUST 12 A GASTRIC SLEEVE PROCEDURE WAS PERFORMED WITH A COOLSEAL TRINITY. DURING THE PROCEDURE, THE DOCTOR DID 5 OR 6 CUTS ALONG THE STOMACH LINE AND TRIED TO SEAL THE VESSEL WHICH WAS UNDER 7MM, THE DEVICE WAS NOT SEALING AND THE DOCTOR ENCOUNTERED 2ML OF BLEEDING ON AT LEAST TWO OCCASIONS. THE DOCTOR SWAPPED THE DEVICE IN LESS THAN TWO MINUTES AND WAS ABLE TO CONTROL THE BLEEDING. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20118372 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JULY 10TH, 2024, DURING A SALPINGECTOMY- OOPHORECTOMY, THE PHYSICIAN STARTED TO TAKE SEALS AROUND THE TUBE AND THEN OVARY. TRINITY DEVICE SEEMED TO SEAL FINE AT FIRST BUT SECONDS LATER THE PHYSICIAN NOTICED SEVERE BLEEDING STARTING TO HAPPEN AROUND THE OVARIAN ARTERY. STAFF COULD NOT CONFIRM IF THE SEAL LINE BROKE. THE SURGEON ATTEMPTED TO SEAL MULTIPLE TIMES USING THE TRINITY, BUT THE BLEEDING CONTINUED, AND THEY HAD TO SWITCH TO LIGASURE AND WAS ABLE TO CONTROL THE BLEEDING. THE PROCEDURE WAS COMPLETED USING LIGASURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19912828 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 A RIGHT LOWER LUNG RESECTION/LOBECTOMY WITH A COOLSEAL TRINITY PROCEDURE WAS PERFORMED AND THE SURGEON WENT TO SEAL THE PULMONARY ARTERY, LOCKED JAWS, AND SEALED USING THE TRIPLE SEAL TECHNIQUE BEFORE CUTTING. THE DOCTOR HAD COMPLETE SEAL TONES BUT SHORTLY AFTER THE PULMONARY ARTERY BLED AND THE SURGEON COULD NOT GET THE BLEEDING UNDER CONTROL. THE DOCTOR HAD TO IMMEDIATELY OPEN THE PATIENT UP AND FINISH THE CASE WITH OTHER MODALITIES. THE PATIENT DIDN'T REQUIRE ANY ADDITIONAL MEDICATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19837713 ↗

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