SURGICEL SNoW 2083Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031063600), received between Mar 24, 2021 and Apr 1, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. THE PACKAGE WAS OPENED ONTO THE FIELD AND BEGAN TO BE PLACED IN PATIENT TISSUE WHEN A TINY HOLE WAS DISCOVERED IN PACKAGING. THE SURGEON WAS MADE AWARE IMMEDIATELY. THE ABSORBABLE HEMOSTAT AND ALL CONTAMINATED ITEMS WERE REMOVED FROM THE FIELD, AND ALL SCRUBBED INDIVIDUALS CHANGED GLOVES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014485 ↗
• MalfunctionFeb 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TCAR PROCEDURE ON (B)(6) 2022 AND ABSORBABLE HEMOSTAT WAS USED. AS THE SURGEON WAS DISSECTING TO THE PREVIOUS ARTERIOTOMY, HE FOUND SEVERAL PIECES OF WHAT HE ASSUMED WAS UNDISSOLVED SURGICEL SNOW. HIS NORMAL PRACTICE IS TO PLACE A FEW STRIPS OF SNOW ON THE ARTERIOTOMY PRIOR TO CLOSING THE TISSUE OVER THE ARTERY. HE NOTED THAT IT DID NOT CREATE ANY ISSUES AND HAD NO BEARING ON THE CLINICAL ISSUE THAT REQUIRED THE REOPERATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439919 ↗
• MalfunctionMar 17, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON (B)(6)2022 AND ABSORBABLE HEMOSTAT WAS USED. AT THE TIME OF OPENING THE PACKAGE, AN ABNORMALITY OF HEAT SEAL WAS NOTICED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796053 ↗
• MalfunctionMar 24, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. BEFORE USE ON THE PATIENT, THE SURGEON NOTED THE THERE WAS A PACKAGE AIR LEAKAGE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566592 ↗