RegWardenFDA facility compliance records
Recall

Class II — Maquet Cardiovascular, LLC

Recalling firmMaquet Cardiovascular LLC
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonIncorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
ProductMaquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Quantity110 units
DistributionWorldwide - 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.
Initiated2025-03-10
Classified2025-04-16
Recall numberZ-1577-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Maquet Cardiovascular, LLC (Z-1577-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96392/

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