510(k) · Cleared
Recalled · Class I · 2026Vasoview Hemopro 2 Endoscopic Vessel Harvesting System
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 Jun 11, 2010 as substantially equivalent to K052274 (Guidant Corporation, 2005) and 1 other predicate after a 36-day review. Its family tree reaches back 5 generations to 1994. 2 of the 17 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 10 times, including 2 Class I recalls.
- Decided
- Jun 11, 2010
- Review
- 36 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 10 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945975 (1994). 12 ancestors in all, the oldest K904993 (1991). 4 later devices descend from it, 3 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 4 generations backK020143 Vasoview 5 Harvesting CannulaGuidant Corporation, Cardiac Surgery · 2002 · Recalled
- 3 generations backK022718 Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002Guidant Corporation, Cardiac Surgery · 2002
- 2 generations backK041981 Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant…Guidant Corporation · 2004 · Recalled
- 1 generation backK052274 Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model…Guidant Corporation · 2005 · Recalled (Class I)
- This deviceK101274 Vasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC · 2010
- Descendant · cites it directly · 2 of its ownK233879 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2024
- Descendant · cites it directly · 0 of its ownK251238 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)…Maquet Cardiovascular, LLC · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK243918 Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025
- Descendant · cites it directly · 0 of its ownK191947 VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension…Maquet Cardiovascular, LLC · 2019
Class I recalls in this family
- K052274 Guidant Vasoview Hemopro Endoscopic Vessel…direct predicate · 2005
Most influential descendants
Showing 4 of 4 · See all- K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3…Maquet Cardiovascular, LLC · 2024 · cites it directly2descendants
- K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3…Maquet Cardiovascular, LLC · 2025 · cites it directly0descendants
- K243918Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025 · 2 generations on0descendants
- K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension…Maquet Cardiovascular, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −4 | K020143 | Vasoview 5 Harvesting Cannula | Guidant Corporation, Cardiac Surgery | 2002 | 1 |
| −3 | K022718 | Vasoview 6 Harvesting Cannula, Models VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | 2002 | — |
| −2 | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6… | Guidant Corporation | 2004 | 2 |
| −1 | K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000 | Guidant Corporation | 2005 | Class I |
| 0 (this device) | K101274 | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System | Maquet Cardiovascular, LLC | 2010 | — |
| +1 | K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview… | Maquet Cardiovascular, LLC | 2024 | — |
| +1 | K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview… | Maquet Cardiovascular, LLC | 2025 | 1 |
| +2 | K243918 | Vasoview Hemopro 3 Power Supply | Maquet Cardiovascular, LLC | 2025 | — |
| +1 | K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar… | Maquet Cardiovascular, LLC | 2019 | — |
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 |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K052274 | Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Summary page 1…e substantially equivalent with regard to those features in the predicate VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System (K052274), and with regard to the spot cautery element in the VasoView 6 Harvesting Cannula (K(041981). Device… | 2005 |
| * | K041981 | Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack…Summary page 1…RO Endoscopic Vessel Harvesting System (K052274), and with regard to the spot cautery element in the VasoView 6 Harvesting Cannula (K(041981). Device The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is description designed for use in conjuncti… | 2004 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3… | 2024 | 2 |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3… | 2025 | 0 |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension… | 2019 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2026 | Class II | Z-2741-2026 | Under Investigation by firm | 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 STERIS at its Whippany, NJ facility… |
| Mar 20, 2025 | Class II | Z-1622-2025 | Under Investigation by firm | 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 potential to break while in use.… |
| Mar 10, 2025 | Class II | Z-1577-2025 | Under Investigation by firm | 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 | Device Design | 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 | Device Design | 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 | Under Investigation by firm | 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 distance between C-Ring and Harvesting… |
| May 17, 2024 | Class II | Z-2175-2024 | Device Design | 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 | Process control | Some batches of product were not sterilized to their minimum sterilization specification. |
| Dec 22, 2022 | Class II | Z-0995-2023 | Under Investigation by firm | 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 embolic event. |
| 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" |
The 5 latest of 10 recalls; the web page lists all.
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.
- K052274Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model VH-3000Guidant Corporation · 2005 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233879 (Maquet Cardiovascular, LLC, 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K052274.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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…
Read the full statement (131 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101274: Vasoview Hemopro 2 Endoscopic Vessel Harvesting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101274
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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