Z-1577-2025Class II

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

Name: Z-1577-2025 Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System...
Creator: Maquet Cardiovascular, LLC
Published: 2025-03-10
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2025-03-10 / Open, Classified

FDA source

Maquet Cardiovascular, LLC began a recall of Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2) on 2025-03-10. FDA classified it as Class II and gives the reason as "Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1577-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-10
Posted: 2025-04-16
Recalling firm: 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).
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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 root 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.
Product 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1577-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1577-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16

Product code GEI

K101274Class IIVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC / cleared 2010-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)