Vasoview Hemopro
2 catalogue numbers from VH-3000, listed by Maquet Cardiovascular LLC, United States, under Electrosurgical, Cutting & Coagulation & Accessories. 65 manufacturers in China are registered for this product code.
65manufacturers in China registered for this device type
2catalogue numbers in this listing
8510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Maquet Cardiovascular LLC, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K052274 |
| Record published | 2016-09-24 |
| Record revised | 2024-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-10-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VH-3000 | Withdrawn | |
| VH-3500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251238 | 2025-05-30 |
| K243918 | 2025-02-26 |
| K233879 | 2024-02-27 |
| K191947 | 2019-09-17 |
| K153194 | 2016-04-19 |
| K132743 | 2013-12-03 |
| K101274 | 2010-06-11 |
| K091733 | 2009-08-28 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Maquet Cardiovascular LLC | 510(k) number | 2024-09-20 | Class I | Device Design | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. | 28,809 units | |
| Maquet Cardiovascular LLC | 510(k) number | 2024-05-31 | Class II | 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 Tool | 600 units | |
| Maquet Cardiovascular LLC | 510(k) number | 2024-05-17 | Class II | 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. | 37,186 units | |
| Maquet Cardiovascular LLC | 510(k) number | 2023-12-01 | Class II | 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 bypas | 554 units (OUS) | |
| Maquet Cardiovascular LLC | 510(k) number | 2023-12-01 | Class II | 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 bypas | 38,094 units (US) | |
| Maquet Cardiovascular LLC | 510(k) number | 2023-03-06 | Class II | Process control | Some batches of product were not sterilized to their minimum sterilization specification. | 900 units | |
| Maquet Cardiovascular LLC | 510(k) number | 2023-03-06 | Class II | Process control | Some batches of product were not sterilized to their minimum sterilization specification. | 235 units | |
| Maquet Cardiovascular LLC | 510(k) number | 2017-01-27 | Class II | Under Investigation by firm | Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power. | 4283 units | 2018-04-12 |
| Maquet Cardiovascular LLC | 510(k) number | 2013-10-30 | Class II | 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” | 12,259 units | 2015-04-24 |
| Maquet Cardiovascular LLC | 510(k) number | 2009-12-17 | Not classified | 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. | 72 units | 2011-09-21 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-02 | Class II | 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 between | 205 units | |
| 2025-08-06 | Class II | 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 out | 98 units | |
| 2025-03-20 | Class II | 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. Maquet/Getinge | 22,244 units | |
| 2025-03-10 | Class II | 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. | 110 units | |
| 2024-12-09 | Class I | Device Design | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool | 11,101 units US | |
| 2024-12-09 | Class I | Device Design | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool | 418,076 units (326,608 US, 91,468 OUS) | |
| 2024-05-31 | Class II | 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 Tool | 2463 units units US /330 units OUS | |
| 2024-05-17 | Class II | 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. | 430,037 units | |
| 2023-09-19 | Class II | Under Investigation by firm | Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. | ||
| 2023-03-06 | Class II | Process control | Some batches of product were not sterilized to their minimum sterilization specification. | 2300 units | |
| 2022-12-22 | Class II | 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. | 9817 devices | |
| 2009-12-17 | Not classified | 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. | 141 units | 2011-09-21 |
| 2009-12-17 | Not classified | 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. | 177 units | 2011-09-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.