# K153194: VASOVIEW HemoPro Endoscopic Vessel Harvesting System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiovascular, LLC
- Decided: Apr 19, 2016 after 167 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 7 (1 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.
1 later device descends from it; 1 cites it directly.
2 of 14 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 4.

## Most influential descendants
- 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
- Sep 20, 2024 · Class I · Z-0092-2025: There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
- May 31, 2024 · Class II · Z-2337-2024: 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-2176-2024: 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.
- Dec 1, 2023 · Class II · Z-0724-2024: Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for pati
- Mar 6, 2023 · Class II · Z-1335-2023: Some batches of product were not sterilized to their minimum sterilization specification.
- Mar 6, 2023 · Class II · Z-1337-2023: Some batches of product were not sterilized to their minimum sterilization specification.
- Jan 27, 2017 · Class II · Z-1456-2017: Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.

## Indications for use
The VASOVIEW HEMOPRO 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 the 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/K153194
Methodology: https://510kreport.com/methodology