Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000

• • Ongoing Z-0092-2025 FDA Class I ·initiated 20 Sep 2024

  There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

• • Ongoing Z-0723-2024 FDA Class II ·initiated 1 Dec 2023

  Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.

• • Terminated Z-0466-2014 FDA Class II ·initiated 30 Oct 2013

  Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"

• • Terminated Z-3272-2011 FDA Unclassified (pre-2012) ·initiated 17 Dec 2009

  During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.

510(k) Number

K052274 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Guidant Corp. →