VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System C-Ring Break
Maquet Cardiovascular is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a ceramic C-Ring component that may break during use. At least 12 user complaints were reported as of March 3, 2025.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a surgical device with a documented component fracture defect in at least 12 reported cases. The potential for device failure during a surgical procedure poses a risk of harm (intraoperative complication), though no injuries or hospitalizations have been explicitly reported in the source text. The hazard is substantiated by actual field complaints rather than purely theoretical.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System (Model Nos. VH-4000 and VH-4001). The device is designed for endoscopic vessel harvesting during cardiovascular surgery. The ceramic C-Ring component housed within the harvesting cannula has a potential to break while the device is in use.
As of March 3, 2025, at least 12 user complaints reported that the ceramic C-Ring was identified as broken in half during device operation. The issue is limited to units manufactured with ceramic C-Ring components between November 5, 2024, and February 14, 2025. A total of 22,244 units have been distributed worldwide, including to the United States and internationally to Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, and New Zealand.
Healthcare facilities and clinicians should stop using affected lots and contact Maquet Cardiovascular for instructions on product return or replacement. Specific lot/serial numbers are identified in FDA documentation. Users with questions should contact the manufacturer.
The recalled product
- Product
- The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is 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…
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 22,244
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-4000 (Hemopro 2)
- VH-4001 (Hemopro 2 w/ Vasoshield)
- UDI-DI: 00607567700406 (Hemopro 2)
- 00607567700451 (Hemopro 2 w/ Vasoshield)
- Lot/Serial No. 3000436447
- 3000437191
- 3000439557
- 3000439600
- 3000439623
- 3000439922
- 3000440187
- 3000440220
- 3000440283
- 3000440754
- 3000440957
- 3000440981
- 3000440982
- 3000441144
- 3000441319
- 3000441541
Distribution
Distributed nationwide across the United States.
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