HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch
Medical device recall Z-1872-2020. 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: M00202175828P0 - 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: 1069016915 1069016778 1069024392 1069023633 1069020945 1069017069 1069887359 1070175211 1070689212 1070691938 1070692229 1073307657 1073274083 1074239734 1074508943 1076726963 1076724195 1076691012 1080515527 1080502574…
Every code shown here, 1,996 characters
Serial Numbers: 1069016915 1069016778 1069024392 1069023633 1069020945 1069017069 1069887359 1070175211 1070689212 1070691938 1070692229 1073307657 1073274083 1074239734 1074508943 1076726963 1076724195 1076691012 1080515527 1080502574 1080516052 1080521115 1080517807 1080517202 1080511104 1082496280 1107410936 1107401196 1107412006 1108349382 1108384849 1109527236 1109536351 1109582959 1109545837 1109638521 1109712993 1112019301 1112016613 1112016964 1112016730 1112017860 1112017489 1112018385 1112051221 1112030283 1113457118 1113461382 1113412574 1113446562 1113429579 1115826461 1115864128 1115914431 1115914548 1115827123 1115899734 1115897708 1115825331 1115890109 1115890226 1116687063 1116670058 1116665366 1116796185 1118783633 1118872362 1118683489 1118680938 1118706076 1118855516 1118677296 1118857425 1118863618 1118853607 1118865156 1118868449 1120124949 1120151826 1120162616 1120197246 1120115580 1121427175 1121369492 1121368479 1121432004 1121402790 1121367720 1121381761 1121406257 1121461746 1121476608 1123956748 1124038791 1126619737 1126648874 1126652924 1126635453 1126606550 1139533672 1139548534 1139546508 1139558662 1139544833 1139556753 1139580083 1143639633 1145774258 1145827483 1145775271 1145857887 1146721149 1146735095 1146730264 1146737492 1146826241 1146794051 1146827488 1148863022 1150323725 1150325029 1150370975 1150390392 1150368503 1150338567 1150381414 1150319792 1150511214 1150545319 1150343259 1150599075 1150400300 1150603119 1151562307 1152518823 1152580288 1152720119 1152745089 1152748987 1152536448 1152735683 1152740863 1152618108 1160497045 1160563181 1160479908 1161618086 1161644067 1162218200 1162252517 1163879834 1163823544 1177064705 1177726014 1177810868 1177845264 1177799150 1177805708 1177743114 1177779362 1177757294 1177825964 1177745140 1177845030 1177719159 1177852470 1177816595 1177746524 1177754509 1177736376 1179122144 1179142049 1179115543 1181358135 1181256570 1181240695 1181268490 1183390553 1183404630 1183478311…
FDA’s list runs to 2,292 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 2,292 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.