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FDA · Medical device recall

Maquet VH-3010 Power Supply…

Recall started · FDA enforcement report April 23, 2025 Class II

Reason
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Status
Ongoing
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…

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Enforcement report date
April 23, 2025
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
Maquet Cardiovascular, LLC
Product
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Reason
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
Distribution pattern
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.
Quantity
110 units
Codes and lots
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.
Recall started
March 10, 2025
Voluntary or mandated
Voluntary: Firm initiated
Device type
Electrosurgical, Cutting & Coagulation & Accessories
Root cause (FDA)
Under Investigation by firm
What the company told customers
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.
Recall number
Z-1577-2025

What this record is about

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A generic icon of the kind of thing the record is aboutA simplified icon of the kind of thing the record is about and the phrases of the record's own text beside it.1 The record: Maquet VH-3010 Power Supply. Used…2 In the record's words:3 Only the kind of thing is drawn4 The record's own words are below“Incorrect resistor utilized in the VH-3010 Power Supply, which maycause the jaws of the HemoPro 2 to not adequately heat up.”MAQUET VH-3010 POWER…

“Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.”Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)., FDA enforcement report, 2025-04-23. The caption is the record's own words.

The picture shows the kind of thing the record is about (a part, a product, a package), not the product itself; the ring marks it. Nothing in it is a claim beyond the record's own words below.

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FDA device name: Electrosurgical, Cutting & Coagulation & Accessories

Distributed in (FDA's record): Alabama California Colorado District of Columbia Florida Georgia Idaho Illinois Indiana Iowa Kentucky Maryland Michigan Minnesota Missouri New Hampshire New Jersey New York North Carolina Ohio Pennsylvania Puerto Rico Texas Utah Virginia West Virginia Wisconsin and nationwide

This recall among the others

  • FDA's enforcement report came 44 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
  • Maquet Cardiovascular: 15 other recalls or notices on this site in the three years before this one (from April 24, 2022).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-1577-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-1577-2025, April 23, 2025. "Maquet VH-3010 Power Supply." PlainRecords, https://plainrecords.com/recall/device/z-1577-2025/ (as of the day it was built).

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