CoolSeal™ Trinity CSL-TR105-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850346007061), received between Sep 2, 2024 and Sep 2, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Seal” (3 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, 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 5 most recent of 5 reports, 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 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 ↗
• 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 ↗
• 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 ↗