FDA Medical Device Recalls (openFDA)
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. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
- Recall number
- Z-2175-2024
- Recalling firm
- Maquet Cardiovascular, LLC
- 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. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.
- Status
- Open, Classified
- Initiated
- 2024-05-17
- Posted
- 2024-06-24
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 430,037 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia Brazil, Canada, China, EEA, India, Korea, New Zealand, Southern Africa, Taiwan, Thailand, Turkey, & United Kingdom.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K101274"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28