510(k) · Cleared
Recalled · Class II · 2025Vasoview 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiovascular, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 30, 2025 as substantially equivalent to K101274 (Maquet Cardiovascular, LLC, 2010) and 1 other predicate after a 38-day review. Its family tree reaches back 7 generations to 1994. 2 of the 15 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- May 30, 2025
- Review
- 38 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K945975 (1994). 14 ancestors in all, the oldest K904993 (1991). No later device cites it as a predicate yet. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 6 generations backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- 5 generations backK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- 4 generations backK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004 · Recalled
- 3 generations backK052274 Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model…Guidant Corporation · 2005 · Recalled (Class I)
- 2 generations backK101274 Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010 · Recalled (Class I)
- 1 generation backK233879 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2024
- This deviceK251238 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −6 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| −5 | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002 | — |
| −4 | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6… | Guidant Corporation | 2004 | 2 |
| −3 | K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000 | Guidant Corporation | 2005 | Class I |
| −2 | K101274 | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | 2010 | Class I |
| −1 | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview… | Maquet Cardiovascular, LLC | 2024 | — |
| 0 (this device) | K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview… | 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 |
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.
2 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101274 | Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemSummary page 5…II Legally Marketed Predicate Device(s) 510(k) Number Product Code Vasoview Hemopro 2 Endoscopic Vessel K101274 GEI Harvesting System Vasoview Hemopro 3 Endoscopic Vessel K233879… | 2010 |
| * | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…Summary page 5…Vasoview Hemopro 2 Endoscopic Vessel K101274 GEI Harvesting System Vasoview Hemopro 3 Endoscopic Vessel K233879 GEI Harvesting System Page 2 of 4 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2025 | Class II | Z-2636-2025 | Under Investigation by firm | Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed… |
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K101274.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 Hemopro 3 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…
Read the full statement (151 words)
The Vasoview Hemopro 3 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.
The Vasoview Hemopro 3 Power Supply is used in conjunction with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251238 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251238
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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