Recall Z-0723-2024— Maquet Cardiovascular, LLC

Name: FDA recall Z-0723-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-01

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2023-12-01. It names one FDA 510(k) clearance: K052274. Product: Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .. Reason: 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..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-12-01
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K052274 — GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000Guidant Corporation·cleared 2005-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.