The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len

FDA device recall Z-1622-2025 · posted 2025-04-18 · Open, Classified

Recall details

Recalling firm

Maquet Cardiovascular, LLC

Reason for recall

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.

Action taken

An URGENT MEDICAL DEVICE NOTIFICATION dated March 2025 was mailed to consignees. The notification provides instructions to users on how to proceed with a procedure if a ceramic C-Ring break occurs. If a consignee has a C-Ring break they are asked to save the device and complete the provided return form so Maquet Cardiovascular can conduct an investigation. Maquet instructs consignees to forward the notification to device users and to facilities to which product was further distributed for their awareness. Consignees are asked to return the provided response form by email to recallresponses.qrc@getinge.com. Questions can be directed to Maquet/Getinge Customer Support at 888-880-2874.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

22,244 units

Distribution

Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand.

Date initiated

2025-03-20

Date posted

2025-04-18

Location

Wayne, NJ

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