Recall Z-0995-2023— Maquet Cardiovascular, LLC

Name: FDA recall Z-0995-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-22

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2022-12-22. It names one FDA 510(k) clearance: K101274. Product: Hemopro 2 with Vasoshield, Model VH-4001. Reason: Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-12-22
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

Hemopro 2 with Vasoshield, Model VH-4001

Reason for recall

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

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