Recall Z-0092-2025— Maquet Cardiovascular, LLC
Class I · Ongoing
Class I FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2024-09-20. It names 2 FDA 510(k) clearances: K153194, K052274. Product: VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500. Reason: There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-09-20
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K153194 — VASOVIEW HemoPro Endoscopic Vessel Harvesting System
- K052274 — GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000
K-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 Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Reason for recall
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.