Recall Z-0712-2025— Maquet Cardiovascular, LLC

Name: FDA recall Z-0712-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-09

Class I · Ongoing

Class I FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2024-12-09. It names one FDA 510(k) clearance: K101274. Product: Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.. Reason: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool.

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class I
Status: Ongoing
Initiated: 2024-12-09
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K101274 — VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEMMaquet Cardiovascular, LLC·cleared 2010-06-11

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 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Reason for recall

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

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