Maquet Cardiovascular, LLC Recall 94700
Description: The VASOVIEW HemoPro 2 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 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 94700 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2175-2024 |
| Event ID | 94700 |
| Event Description | The VASOVIEW HemoPro 2 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 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 | Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom. |
| Quantity | 252,811 units |
| Recall Reason | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. |
| Device Classification | 20240703 |
| Device Code Info | Model No. VH-4000, VH-4001; UDI: 00607567700406, 00607567700451; Lot No. 3000236928, 3000242413, 3000242535, 3000242538, 3000242861, 3000243448, 3000243449, 3000243749, 3000243750, 3000243751, 3000243752, 3000244416, 3000244417, 3000244418, 3000244419, 3000246612, 3000247034, 3000247055, 3000247283, 3000247284, 3000247944, 3000247945, 3000248013, 3000248561, 3000248698, 3000249229, 3000249586, 3000249881, 3000250276, 3000250499, 3000250934, 3000251962, 3000251969, 3000251972, 3000252557, 3000252852, 3000252941, 3000252943, 3000253209, 3000254166, 3000254971, 3000254973, 3000254974, 3000255299, 3000255302, 3000255377, 3000255720, 3000256000, 3000256057, 3000256428, 3000257248, 3000258449, 3000258495, 3000259551, 3000259969, 3000260012, 3000260018, 3000260047, 3000260401, 3000260438, 3000260653, 3000260654, 3000261144, 3000261455, 3000261456, 3000261457, 3000261665, 3000261666, 3000261667, 3000262456, 3000262456, 3000262457, 3000262457, 3000262458, 3000262458, 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3000379692, 3000379867, 3000380264, 3000380314, 3000380475, 3000380671, 3000380847, 3000381049, 3000381101, 3000381155, 3000381287, 3000381397, 3000381620, 3000381751, 3000382054, 3000382138, 3000382562, 3000382876, 3000383017, 3000383299, 3000383367, 3000383699, 3000383779, 3000383810, 3000384088, 3000384101, 3000384413, 3000384627, 3000384783, 3000385584, 3000385859, 3000386685, 3000386988, 3000388588, 3000388676. |
| Center Classification Date | 20240624 |
| Recall Initiation Date | 20240517 |
| Recalling Firm | Maquet Cardiovascular, LLC |
| Initial Notification | Letter |
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