VASOVIEW HemoPro harvesting system fluid ingress may disable cautery
Maquet Cardiovascular recalls VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems due to fluid ingress into the harvesting tool handle, which may prevent necessary cautery or cause unintended cautery during surgical procedures.
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: FDA Class II medical device recall with no reported illnesses or injuries. The defect represents a risk-of-harm to surgical outcomes through potential device malfunction during critical procedures, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Maquet Cardiovascular, LLC is recalling 37,186 units of the VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems (Models VH-3500 and VH-3000-W). These surgical systems are designed for use with a 7 mm extended length endoscope during vessel harvesting procedures in cardiovascular surgery. The harvesting cannula includes four lumens and a harvesting tool with curved jaws containing heating elements for branch cutting and cauterization.
The recall was initiated due to a potential for fluid ingress into the handle of the harvesting tool. This defect may result in the device either failing to provide the necessary cautery (cutting and cauterization) when needed during the procedure, or providing cautery when it was not intended. Both scenarios could compromise the effectiveness and safety of the surgical procedure.
The affected devices have been distributed worldwide, including throughout the United States, Australia, Brazil, Canada, China, European Economic Area countries, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, and the United Kingdom. Multiple lot numbers are identified in the FDA recall notice.
Clinicians and healthcare facilities that use VASOVIEW HemoPro systems should review their inventory against the affected lot numbers and contact Maquet Cardiovascular, LLC for guidance on replacement or remediation of affected devices.
The recalled product
- Product
- The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- fluid-ingress
- cautery-failure
- unintended-activation
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 (20)
- Model No. VH-3500
- VH-3000-W
- UDI: 00607567701250
- 00607567700345
- Lot No. 3000314373
- 3000314821
- 3000316023
- 3000316024
- 3000316027
- 3000317501
- 3000317575
- 3000317576
- 3000318302
- 3000318901
- 3000320140
- 3000320141
- 3000320773
- 3000321483
- 3000321723
- 3000323214
Distribution
Distributed nationwide across the United States.
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