FDA Medical devices recall ·
Maquet VH-3010 Power Supply recall
- Recall number
- Z-1577-2025
- Date
- (initiated March 10, 2025)
- Company / brand
- Maquet Cardiovascular, LLC
45 Barbour Pond Dr, Wayne, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 110 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Why was it recalled?
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
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.
States: Alabama California Colorado District of Columbia Florida Georgia Iowa Idaho Illinois Indiana Kentucky Maryland Michigan Minnesota Missouri North Carolina New Hampshire New Jersey New York Ohio Pennsylvania Puerto Rico Texas Utah Virginia Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1577-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.