Recall Z-1577-2025— Maquet Cardiovascular, LLC

Name: FDA recall Z-1577-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-10

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2025-03-10. It names one FDA 510(k) clearance: K101274. Product: Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).. Reason: Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-10
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

Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).

Reason for recall

Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.

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