Maquet Cardiovascular, LLC The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. Th Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. Th
Brand
Maquet Cardiovascular, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
1. Model Number: VH-4000. UDI-DI: 00607567700406. All lot numbers within expiration. 2. Model Number: VH-4001. UDI-DI: 00607567700451. All lot numbers within expiration.
Maquet Cardiovascular, LLC is recalling The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView H due to 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 caut. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees were mailed an URGENT MEDICAL DEVICE - CORRECTION notice, dated 5/17/24. In the notice consignees are instructed to make users aware of the additional safety information provided in the notification by forwarding the notice to users in their facility and locations where devices are stored. Additionally, consignees are asked to return the provided response form by email to VVHemoPro2024.act@getinge.com or by fax to 800-892-0487. Getinge will be updating the Instructions for Use (IFU) of devices to include the additional safety information related to fluid ingress. Questions can be directed to Customer Support at 888-880-2874, Monday through Friday from 6:00 AM to 5:00 PM PST. UPDATE: On 07/11/2025 an updated Urgent Medical Device Correction Update letter was posted on Getinge.com and sent to consignees via letter. The updated communication informs users that the Instructions for Use (IFU) for the Vasoview Hemopro 2 EVH System has been revised to include warnings and precautions regarding fluid ingress into the handle of the Harvesting Tool. Consignees were instructed to review the updated IFU, view the training video linked in the letter, complete and return the Medical Device Correction Response form, and notify customers if product was further distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026