Reported May 13, 2020 · Terminated

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use…

Maquet Cardiovascular, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

  • HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch
  • Product CodeM00202175820P0 -
  • Product Usagefor use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
Lot codes and dates
  • Serial Numbers
    • 1120090850
    • 1120109758
    • 1120080956
    • 1120074392
    • 1120099148
    • 1137597566
    • 1137603753
    • 1183458035
Amount recalled
N/A

This recall covers 24 products

The agency filed one notice per product. You are reading one of them; the other 23 are below.

11 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 5, 2021 · Data as of Sep 19, 6:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.