Maquet Cardiovascular, LLC Recall 94802
Description: The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems 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.
Maquet Cardiovascular, LLC Recall 94802 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2337-2024 |
| Event ID | 94802 |
| Event Description | The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems 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. |
| Product Type | Devices |
| Distribution | NationwideForeign: AT DE DK ES GB HK IT NL ZA |
| Quantity | 600 units |
| Recall Reason | 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. |
| Device Classification | 20240717 |
| Device Code Info | UDI-DI: 00607567700345 Lot Numbers; 3000371260 3000378288 3000362934 3000371798 3000378554 3000372477 3000378950 3000376542 3000380314 3000377320 3000380847 |
| Center Classification Date | 20240711 |
| Recall Initiation Date | 20240531 |
| Recalling Firm | Maquet Cardiovascular, LLC |
| Initial Notification | Letter |
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