Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)

FDA device recall Z-1577-2025 · posted 2025-04-16 · Open, Classified

Recall details

Recalling firm

Maquet Cardiovascular, LLC

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

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, Ne

Date initiated

2025-03-10

Date posted

2025-04-16

Location

Wayne, NJ

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