Hemashield M002000195090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401017905), received between Jun 30, 2017 and Jun 30, 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.

• MalfunctionJun 30, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE HOSPITAL REPORTED THAT DURING PREPARATION TO USE THE PATCH, THE INVOLVED PRODUCT PACKAGE WAS STICKY. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO CONSEQUENCE FOR THE PATIENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6680643 ↗

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.