FDA-Device2026-07-22Class IIPROCESSING DEFECT

Maquet Vasoview Hemopro 2 vessel harvesting system recalled for inadequate sterilization

OTHERNationwide distributionMedical devices

What this means

Maquet (now Getinge) identified that 205 units of the Vasoview Hemopro 2 endoscopic vessel harvesting system from a single lot were exposed to an incorrect sterilization dose during gamma sterilization processing. This occurred at a STERIS facility in New Jersey in late March 2026. The affected devices may not be adequately sterilized.

If you have a device from Lot 3000547797, contact your Maquet or Getinge representative immediately for instructions.
Do not use affected devices until you receive guidance from the manufacturer.
Report any adverse events to the FDA MedWatch program.

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.

Affected count

205 units

Manufactured in

45 Barbour Pond Dr, Wayne, NJ, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2741-2026

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