Reported May 13, 2020 · Terminated

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - 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 Graft01 Branch
  • Product CodeM00202175834P0 -
  • Product Usagefor use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
Lot codes and dates
  • Serial Numbers
    • 1069033761
    • 1069030839
    • 1071600069
    • 1071620833
    • 1071615770
    • 1071620950
    • 1074557517
    • 1074562931
    • 1077531880
    • 1109551893
    • 1109625685
    • 1113411073
    • 1115932310
    • 1160529586
    • 1160492194
    • 1160491552
    • 1160727457
    • 1160529957
    • 1182769563
    • 1182780936
    • 1182789351
    • 1182792017
    • 1183481796
    • 1069032514
    • 1115876907
    • 1115936362
    • 1137588685
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?

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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, 6:11 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.