Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
Maquet Cardiovascular is recalling Vasoview Hemopro 2 devices from Lot 3000547797 due to exposure to out-of-specification sterilization during gamma sterilization. The affected devices may not be properly sterilized.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving potential sterilization failure—a risk-of-harm condition where improper sterilization on medical devices could lead to infection or adverse outcomes. No illnesses or injuries have been reported, but the hazard is not merely theoretical; it is a documented process failure affecting actual distributed units.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Vasoview Hemopro 2 Endoscopic Vessel Harvesting System devices (Model VH-4000, UDI 00607567700406) from Lot 3000547797. The recall was initiated after Getinge identified that these devices 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, 2026.
The affected devices may not meet sterilization specifications and could pose a risk if used in clinical procedures. A total of 205 units were distributed nationwide to facilities in New York, California, South Carolina, Florida, Texas, Georgia, and Oregon.
Consumers and healthcare providers who have received devices from this lot should stop use immediately and contact Maquet Cardiovascular for instructions on device return or replacement. Healthcare facilities should verify lot numbers and quarantine any affected inventory.
The recalled product
- 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.
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- sterilization-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 00607567700406
- Serial/Lot Number 3000547797
Distribution
Distributed nationwide across the United States.
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