CoolSeal™ Trinity CSL-TR105-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850346007030), received between Feb 14, 2022 and Aug 1, 2025 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionOct 20, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A COOLSEAL PROCEDURE ON (B)(6) 2023, THE PHYSICIAN WAS PERFORMING AN OVARIAN SURGERY AND IN THE MIDDLE OF THE PROCEDURE IT WAS NOTICED THAT A PIECE OF THE OF THE COOLSEAL BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE PIECE OF THE DEVICE AND NO PATIENT INJURY WAS REPORTED. PROCEDURE WAS COMPLETED WITH SAME DEVICE AND NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981243 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER ENCOUNTERED SIGNIFICANT BLEEDING WHILE USING COOLSEAL TRINITY.

  Patient problems: Intra-Abdominal Hemorrhage

  MAUDE report 13524232 ↗