The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is… — Class II medical device recall Z-2338-2024
Ongoing recall by Maquet Cardiovascular, LLC, reported 2024-07-17. There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting
| Recall number | Z-2338-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2024-05-31 |
| Classified | 2024-07-11 |
| Reported by FDA | 2024-07-17 |
| UPC / GTIN / UDI-DI | 00607567700406, 00607567700451 |
| Lot numbers | 3000362934, 3000371260, 3000371798, 3000372477, 3000376542, 3000377320, 3000378288, 3000378554, 3000378950, 3000380314, 3000380847 |
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 cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
Reason for recall
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2338-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.