510(k) · Cleared
Recalled · Class I · 2024Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 21, 2005 as substantially equivalent to K030512 (Guidant Corp., 2003) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1994. 3 of the 19 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- Sep 21, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 4 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945975 (1994). 11 ancestors in all, the oldest K904993 (1991). 7 later devices descend from it, 3 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 3 generations backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- 2 generations backK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- 1 generation backK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004 · Recalled
- This deviceK052274 Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model…Guidant Corporation · 2005
- Descendant · cites it directly · 4 of its ownK101274 Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK233879 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2024
- Descendant · cites it directly · 1 of its ownK153194 VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK251238 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK243918 Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · cites it directly4descendants
- K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…Maquet Cardiovascular, LLC · 2024 · 2 generations on2descendants
- K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2016 · cites it directly1descendant
- K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3…Maquet Cardiovascular, LLC · 2025 · 2 generations on0descendants
- K243918Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −3 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| −2 | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002 | — |
| −1 | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6… | Guidant Corporation | 2004 | 2 |
| 0 (this device) | K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000 | Guidant Corporation | 2005 | — |
| +1 | K101274 | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | 2010 | Class I |
| +2 | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview… | Maquet Cardiovascular, LLC | 2024 | — |
| +1 | K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | 2016 | Class I |
| +2 | K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview… | Maquet Cardiovascular, LLC | 2025 | 1 |
| +3 | K243918 | Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 1 |
| 2013 | 1 | 0 |
| 2016 | 1 | 1 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2024 | Class I | Z-0092-2025 | Device Design | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. |
| Dec 1, 2023 | Class II | Z-0723-2024 | Component design/selection | 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 patients undergoing a coronary artery… |
| Oct 30, 2013 | Class II | Z-0466-2014 | Component design/selection | Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1" |
| Dec 17, 2009 | Not classified | Z-3272-2011 | Nonconforming Material/Component | During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K101274Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K101274 (Maquet Cardiovascular, LLC, 2010) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K030512.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The VasoView® HemoProTM 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 or extremities, dissection of ducts and…
Read the full statement (129 words)
The VasoView® HemoProTM 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 or 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052274: Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026