Hemashield M002000196270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401018827), received between Sep 29, 2021 and Jan 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

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

• MalfunctionJan 9, 2023Product Quality Problem; Product Quality Problem

  COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121435 ↗
• MalfunctionSep 29, 2021Product Quality Problem; Product Quality Problem

  DETAILS OF THE PROBLEM: SCHEDULED TO BE USED AS A PATCH DURING HEART SURGERY AT THE ABOVE FACILITY ON (B)(6) 2021. WHEN I TOOK IT OUT OF THE BOX, I SAW SOMETHING LIKE A STAIN ON THE SURFACE. THE STAFF ASKS FOR ANALYSIS ON SUSPICION OF PRODUCT DEFECTS. OTHER THAN THE RELEVANT PART IS USED, AND THERE IS NO EFFECT ON SURGERY. I WILL ATTACH A PHOTO OF THE PRODUCT. CASE, PLACE OF USE : A PATCH WAS USED IN THE LUMEN OF THE LEFT CHAMBER IN LEFT VENTRICULAR REDUCTION. REQUEST FOR FUTURE RESPONSE: WE WILL RETURN THE UNUSED PART, SO WE REQUEST A CLOSE EXAMINATION AND ANALYSIS. ARE THERE ANY REPORTS ON THE SAME LOT? IS IT POSSIBLE TO CHECK SAFETY AT THE SAME LOT? ALSO, HAVE THERE BEEN SIMILAR BUG REPORTS IN THE PAST? WE REQUEST A LETTER FOR THE CUSTOMER WITH THE CONTENTS SUCH AS. COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546867 ↗

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.