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

FDA device recall Z-0092-2025 · posted 2024-10-25 · Open, Classified

Recall details

Recalling firm

Maquet Cardiovascular, LLC

Reason for recall

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

Action taken

An URGENT MEDICAL DEVICE- REMOVAL notification letter dated 9/20/24 was sent to customers. Actions to be taken by the customer: 1. Forward this information to all current and potential VasoView HemoPro Endoscopic Vessel Harvesting System users within your hospital/facility. 2. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. 3. Examine your inventory immediately to find and remove from use any of the VasoView HemoPro EVH Systems with the product codes and lot numbers listed in this notice. 4. Return any unused/unexpired affected product to MCV /Getinge. Contact MCV/Getinge Customer Service at 1-888-880-2874 between 6 am and 5 pm PST (Pacific Standard Time) to request a return authorization number (RMA) and shipping instructions. If you have an affected product, you are entitled to a credit. 5. Whether or not you have affected the product, please complete and sign the MEDICAL DEVICE REMOVAL - RESPONSE FORM (page 5) to acknowledge receipt of this notification. Return the completed form to MCV/Getinge by emailing a scanned copy to Hemopro-peeling-detachedsilicone2024.act@getinge.com or by faxing the form to + 1 (866) 594 8101. Actions to be taken by Getinge: MCV/Getinge is continuing to investigate this issue to determine and implement appropriate actions to prevent the recurrence of this failure. MCV /Getinge will notify customers if additional action is needed to address this issue. Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products. This removal only affects the products listed on page 1; no other products are affected by this medical device removal. If you have any questions, contact your MCV /Getinge representative or call the MCV/Getinge Customer Support at 1-888-880-2874, Monday through Friday, between 6 am and 5 pm PST.

Root cause

Device Design

Status

Open, Classified

Product code

GEI

Quantity affected

28,809 units

Distribution

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

Date initiated

2024-09-20

Date posted

2024-10-25

Location

Wayne, NJ

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