# K101274: Vasoview Hemopro 2 Endoscopic Vessel Harvesting System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiovascular, LLC
- Decided: Jun 11, 2010 after 36 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 10 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945975 (1994). 12 ancestors in all.
4 later devices descend from it; 3 cite it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052274: Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000, Guidant Corporation (2005) Summary page 1.
- K041981: Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004, Guidant Corporation (2004) Summary page 1.

## Most influential descendants
- K233879: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) (2024), 2 descendants of its own
- K251238: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) (2025), 0 descendants of its own
- K243918: Vasoview Hemopro 3 Power Supply (2025), 0 descendants of its own
- K191947: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord (2019), 0 descendants of its own

## Recalls of this device
- Jun 2, 2026 · Class II · Z-2741-2026: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STE
- Mar 20, 2025 · Class II · Z-1622-2025: There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potenti
- Mar 10, 2025 · Class II · Z-1577-2025: Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
- Dec 9, 2024 · Class I · Z-0711-2025: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
- Dec 9, 2024 · Class I · Z-0712-2025: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
- May 31, 2024 · Class II · Z-2338-2024: 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 dist
- May 17, 2024 · Class II · Z-2175-2024: 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.
- Mar 6, 2023 · Class II · Z-1336-2023: Some batches of product were not sterilized to their minimum sterilization specification.
- Dec 22, 2022 · Class II · Z-0995-2023: Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral e
- Oct 30, 2013 · Class II · Z-0466-2014: Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"

## Indications for use
The VASOVIEW HEMOPRO 2 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Source page: https://510kreport.com/device/K101274
Methodology: https://510kreport.com/methodology