The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use
Summary
The FDA issued a Class II for The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI by Maquet Cardiovascular, LLC. Reason: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma steri.
Details
Source
Device Recall
External ID
Z-2741-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI 00607567700406, Serial/Lot Number 3000547797
Quantity Affected: 205 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-02
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Maquet Cardiovascular, LLC has 42 FDA actions in our database, including 38 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiovascular, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiovascular, LLC have FDA actions?
Maquet Cardiovascular, LLC has 42 FDA actions in our database, including 38 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2741-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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