RecallRadar

FDA Device recall Z-1864-2020

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the repla…

On 2020-05-13 the FDA classified a Class II recall of HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the repla… by Maquet Cardiovascular, citing potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1864-2020
ClassificationClass II
Statusterminated
Initiated2020-04-07
Published2020-05-13
Last updated2026-09-13 11:55 UTC
CompanyMaquet Cardiovascular
DistributionUS

Product

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.

Reason

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

Identifiers

code_infoSerial Numbers: 1185764630

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1864-2020%22

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