Maquet Cardiovascular, LLC: Device Recall

Recall #Z-0092-2025 · 09/20/2024

Class I: Dangerous

Recall Details

Recall Number: Z-0092-2025
Classification: Class I
Product Type: Device
Recalling Firm: Maquet Cardiovascular, LLC
Status: Ongoing
Date Initiated: 09/20/2024
Location: Wayne, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,809 units

Reason for Recall

There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.

Product Description

VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500

Distribution Pattern

Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.

Other Recalls by Maquet Cardiovascular, LLC

Class II: Risk 08/15/2025

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Class II: Risk 08/15/2025

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Class II: Risk 08/15/2025

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Class II: Risk 08/06/2025

Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Class II: Risk 03/20/2025

There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.

View all recalls by Maquet Cardiovascular, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.