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Maquet Cardiovascular, LLC: The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device tha

Medical DevicesSource: FDA (device) · Date: 2026-07-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Maquet Cardiovascular, LLC
Product
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Reason / hazard
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Recall initiated
2026-06-02
Code info
UDI 00607567700406, Serial/Lot Number 3000547797
Product quantity
205 units
Voluntary mandated
Voluntary: Firm initiated
City
Wayne
State
NJ
Country
United States
Event id
99259
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