CoolSeal™ Generator CSL-200-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850346007023), received between Feb 1, 2022 and Apr 22, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Jan 25, 2022Class IITerminated

   A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.

   Z-0736-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 21886897 ↗
• MalfunctionFeb 1, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A DISTRIBUTOR REPORTED A PATIENT LEAKAGE FAILURE WITH COOLSEAL GENERATOR. IN THIS CASE THERE WAS NO PATIENT IMPACT AS THE ISSUE WAS DISCOVERED BEFORE THE GENERATOR WAS PUT INTO SERVICE.

  Patient problems: Burn(s)

  MAUDE report 13417863 ↗