Recall Z-0711-2025— Maquet Cardiovascular, LLC
Class I · Ongoing
Class I FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2024-12-09. It names one FDA 510(k) clearance: K101274. Product: VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.. Reason: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool.
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-12-09
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Reason for recall
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Data sourced from openFDA. This site is unofficial and independent of the FDA.