Class 2 Device Recall HemoPro 2

• Date Initiated by Firm: March 10, 2025
• Date Posted: April 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1577-2025
• Recall Event ID: 96392
• 510(K)Number: K101274
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
• Code Information: Model No. VH-3010; UDI-DI: 0060756770826; Serial No. H24080065G, H24080074G, H24080012G, H24080022G, H24080184G, H24080185G, H24080051G, H24080117G, H24080069G, H24080016G, H24080079G, H24080041G, H24080056G, H24080030G, H24080068G, H24080034G, H24080058G, H24080026G, H24080033G, H24080020G, H24080032G, H24080053G, H24080066G, H24080077G, H24080144G, H24080123G, H24080042G, H24080070G, H24080008G, H24080003G, H24080174G, H24080064G, H24080027G, H24080044G, H24080047G, H24080049G, H24080061G, H24080078G, H24080010G, H24080138G, H24080080G, H24080006G, H24080015G, H24080038G, H24080085G, H24080084G, H24080031G, H24080101G, H24080148G, H24080040G, H24080055G, H24080025G, H24080052G, H24080048G, H24080093G, H24080126G, H24080073G, H24080007G, H23060082G, H24080075G, H24080113G, H24080127G, H24080011G, H24080005G, H24080013G, H24080023G, H24080057G, H24080110G, H24080009G, H24080067G, H24080029G, H24080043G, H24080183G, H24080165G, H24080017G, H24080001G, H24080037G, H24080060G, H24080072G, H24080076G, H24080045G, H24080024G, H24080028G, H24080114G, H24080136G, H24080062G, H24080018G, H24080054G, H24080063G, H24080112G, H24080118G, H24080071G, H24080182G, H24080002G, H24080004G, H24080014G, H24080019G, H24080021G, H24080035G, H24080036G, H24080039G, H24080046G, H24080050G, H24080059G, H24080081G, H24080082G, H24080083G, H24080125G, H24080186G, H24080189G.
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• Manufacturer Reason for Recall: Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT MEDICAL DEVICE REMOVAL notification dated March 2025 was mailed to consignees. The notification instructs consignees to examine their inventory for impacted serial numbers. For power supplies whose serial numbers are not listed in the provided Appendix A of recalled devices, devices can continue to be used. If power supplies with affected serial numbers are identified as being in stock, the associated devices should not be used and returned to Getinge. Returns are facilitated by contacting Getinge Customer Service at 888-800-2874 between the hours of 6:00 AM and 5:00 PM PST to request a return authorization number and shipping instructions. Consignees are to forward the provided notification to all users of the device within the facility and forwarded to any locations where devices were further distributed. Consignees with any questions about the recall are to contact their Getinge representative.
• Quantity in Commerce: 110 units
• Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, PR, TX, UT, VA, WI, WV and the countries of China, Japan, Netherlands, New Zealand, Singapore, United Kingdom, United States.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEI