Device recall: Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product…

Class II FDA enforcement event 85420. Recall start date: 7 Apr 2020. Status in the FDA record: Terminated. Termination date: 5 Nov 2021.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

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

Maquet Cardiovascular, LLC started this device recall on 7 Apr 2020. The firm address in the FDA record is in Wayne, NJ. FDA put the recall in Class II. FDA event 85420 has 24 product records. The first FDA enforcement report date is 13 May 2020. The record gives the status Terminated, with the termination date 5 Nov 2021.

FDA enforcement report The 24 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy,…

Recalling firm

Maquet Cardiovascular, LLC, Wayne, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

24 product records in the event.

FDA event 85420: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1859-2020	Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1860-2020	Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease	N/A	Class II	Terminated	13 May 2020
Z-1861-2020	Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1862-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1863-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1864-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1865-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1866-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1867-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1868-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1869-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1870-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1871-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1872-2020	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.	N/A	Class II	Terminated	13 May 2020
Z-1873-2020	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.	N/A	Class II	Terminated	13 May 2020
Z-1874-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1875-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1876-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1877-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1878-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1879-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1880-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1881-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020
Z-1882-2020	HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.	N/A	Class II	Terminated	13 May 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 24Median of the firm: 1
Events of the firm on the register: 32

Other events of the firm

Other FDA enforcement events of Maquet Cardiovascular, LLC
Initiated	Product (first record)	Type	Class	Records
2 Jun 2026	The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use	Device	Class II	1
15 Aug 2025	Heartstring III Proximal Seal System. Intravascular anastomosis occluder.	Device	Class II	3
6 Aug 2025	Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Har	Device	Class II	1
20 Mar 2025	The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len	Device	Class II	1
10 Mar 2025	Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)	Device	Class II	1
9 Dec 2024	VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive	Device	Class I	2
16 Oct 2024	Acrobat-i Positioner. Model Number C-XP-5000Z	Device	Class II	3
20 Sep 2024	VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500	Device	Class I	1
31 May 2024	The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng	Device	Class II	2
17 May 2024	The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Numbe	Device	Class II	2

Maquet Cardiovascular, LLC: all 32 events

Official channels

FDA enforcement report Z-1859-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 85420. https://recallregister.com/fda/ii/85420/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy,…
What quantity of product is in FDA event 85420?: The event has 24 product records. The first record gives this quantity: N/A
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.