Drug & Device Safety Atlas

FDA recall record · openFDA

Maquet Cardiovascular, LLC

31 FDA recalls on record (2023–2025) — 31 device. 31 still ongoing.

5
Class I (most serious)
26
Class II
0
Class III
31
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and po 4
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assure 3
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to de 3
Some batches of product were not sterilized to their minimum sterilization specification. 3
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in 2

Recalls

VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 Class I 2024-09-20 VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive Class I 2024-12-09 Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in min Class I 2024-12-09 Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Class I 2023-12-13 Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Class I 2023-12-13 Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Class II 2025-08-15 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel H Class II 2025-08-06 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len Class II 2025-03-20 Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. Class II 2025-08-15 Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2) Class II 2025-03-10 Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. Class II 2025-08-15 Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z Class II 2024-10-16 The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng Class II 2024-05-31 The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Numb Class II 2024-05-17 Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z Class II 2024-10-16 The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Len Class II 2024-05-17 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Len Class II 2024-05-31 Acrobat-i Positioner. Model Number C-XP-5000Z Class II 2024-10-16 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . Class II 2023-12-01 VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 Class II 2023-03-06 Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a s Class II 2023-09-13 VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W Class II 2023-03-06 ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and c Class II 2023-06-28 ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest Class II 2023-06-28 ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and ch Class II 2023-06-28 Fusion Bioline Vascular Graft, Part number M00201503046B0 Class II 2023-01-30 VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 Class II 2023-03-06 Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, o Class II 2023-09-19 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. Class II 2023-12-01 ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and ches Class II 2023-06-28 Acrobat-i Vacuum Positioner System, Model Number XP-5000Z Class II 2023-10-31

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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