HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch
Medical device recall Z-1873-2020. Published in FDA’s Enforcement Report on May 13, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 13, 2020. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1069844373 1069859235 1070838372 1070706306 1070885876 1070696535 1070880206 1070698932 1070693359 1070875260 1070859895 1071599689 1071623404 1071635929 1071640855 1071595383 1072244650 1072221218 1072235164 1073312349…
Every code shown here, 1,665 characters
Serial Numbers: 1069844373 1069859235 1070838372 1070706306 1070885876 1070696535 1070880206 1070698932 1070693359 1070875260 1070859895 1071599689 1071623404 1071635929 1071640855 1071595383 1072244650 1072221218 1072235164 1073312349 1074236187 1074521366 1075883407 1076662460 1076662089 1076657163 1076657651 1077516221 1077516455 1077512637 1077509366 1077515793 1077506795 1077514292 1077510006 1077509132 1080021177 1080028425 1080022190 1080038065 1080016505 1080020047 1080020906 1080022444 1080034247 1080026145 1107350739 1107370878 1107397055 1107542300 1107356954 1107534803 1111727076 1111767628 1111828116 1111802952 1111831484 1111976640 1111962791 1111974477 1111985521 1111988794 1111989573 1111991831 1111960882 1111934296 1113454547 1113439727 1113459983 1113457606 1113464792 1113410548 1113473439 1115874978 1115872835 1115914782 1115896441 1115917119 1115900231 1115900953 1115936616 1115917841 1115915444 1115918249 1116670546 1116664587 1116654947 1116679332 1116771449 1116675865 1116657147 1117803878 1117890119 1117889596 1123969330 1123996558 1124010762 1123975523 1123968785 1124016489 1124033238 1123954839 1124030667 1123982592 1124038069 1123990226 1124016977 1126833792 1129566390 1129565748 1131391775 1134353909 1134350733 1134353284 1134370267 1139544111 1139533926 1139541540 1139536009 1146817477 1150356075 1151513850 1151507306 1151527816 1151544428 1169424559 1169388690 1171544434 1171540733 1171618089 1171564710 1171541375 1173579328 1173699240 1182769446 1182698342 1182756864 1182709126 1184446354 1184412971 1184445946 1184453326 1184450033 1187301116 1187336000 1187866556 1189130132 1189111006 1190531014 1190781708
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 7, 2020.
- FDA classified it on May 4, 2020.
- FDA’s Enforcement Report published it on May 13, 2020.
- FDA terminated it on Nov 5, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Maquet Cardiovascular, LLC, of Wayne, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.