High FDA (Devices)·Z-1622-2025·Announced 2025-04-30

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.

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 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 cauterizin
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Surgical / Cardiovascular
Hazard: device-fracture
component-failure
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.

Same manufacturer · Maquet Cardiovascular, LLC

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