Hemashield M002000195290Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401017875), received between Nov 16, 2017 and Nov 16, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K955349); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE HOSPITAL REPORTED THAT THE PATCH WAS OPENED ON SURGICAL FIELD, AND IT APPEARED DIFFERENT TO THE SURGEON. HE SAW SOMETHING ON THE PATCH WHICH LOOKED STICKY OR GLUE LIKE. THE PATCH WAS NOT IMPLANTED, NO CONSEQUENCE FOR THE PATIENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7036306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955349. One submission often covers many models, so check the product and lot details in each record.

• Z-1172-2018 · Jan 3, 2018 · Terminated
  HEMASHIELD Knitted Double Velour Cardiovascular Fabric
• Z-2062-2010 · May 24, 2010 · Terminated
  Hemashield Double Velour Cardiovascular Fabrics.