Recall Z-1859-2020— Maquet Cardiovascular, LLC

Name: FDA recall Z-1859-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-07

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2020-04-07, terminated 2021-11-05. It names one FDA 510(k) clearance: K954848. Product: Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.. Reason: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts.

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Terminated: 2021-11-05
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFTMeadox Medicals, Div. Boston Scientific Corp.·cleared 1996-02-01

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

Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Reason for recall

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

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