Hemashield Microvel Velour Knitted Vascular Graft

• • Terminated Z-0729-2022 FDA Class II ·initiated 14 Jan 2022

  Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm

• • Terminated Z-0403-2022 FDA Class II ·initiated 1 Dec 2021

  There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

• 3 recalls, same reason

  • Terminated Z-1859-2020 FDA Class II ·initiated 7 Apr 2020
  • Terminated Z-1861-2020 FDA Class II ·initiated 7 Apr 2020
  • Terminated Z-1860-2020 FDA Class II ·initiated 7 Apr 2020

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

• • Terminated Z-2066-2010 FDA Unclassified (pre-2012) ·initiated 24 May 2010

  Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.

510(k) Number

K954848 ↗

FDA Product Code

MAL

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

ST

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See all devices from Meadox Medicals, Div. Boston Scientific Corp. →