—#204970

Product

Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K052274
Affected lot / code info: UDI-DI: 00607567700413, Lots: 3000283735, 3000293031, 3000310304, 3000333956.

Why it was recalled

Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.

Root cause (FDA determination)

Component design/selection

Action the firm took

An Urgent Medical Device Correction notice dated December 1, 2023 was sent via FedEx 2-Day delivery. Please examine your inventory immediately to determine if you have any of the product codes and lot numbers listed in the notice and remove these from use. Return any unused/unexpired affected product to Maquet/Getinge. Please forward this information to all current and potential VasoView HemoPro EVH System users within your hospital / facility. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Maquet/Getinge representative or call the Maquet/Getinge Customer Support at 888-880-2874, Monday through Friday, between the hours of 6 AM to 5 PM (Pacific Standard Time). Whether or not your facility has affected product listed in the notice, please complete and sign the MEDICAL DEVICE REMOVAL - RESPONSE FORM to acknowledge that you have received the notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to VVHemoProParticulate2023.act@getinge.com or by faxing the form to 1-800-878-9105.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: US: OUS: China, Brazil, Hong Kong.

Timeline

Recall initiated: 2023-12-01
Posted by FDA: 2024-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204970. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.