Z-2175-2024Class II

The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2...

Name: Z-2175-2024 The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2...
Creator: Maquet Cardiovascular, LLC
Published: 2024-05-17
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2024-05-17 / Open, Classified / root cause: design

FDA source

Maquet Cardiovascular, LLC began a recall of 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... on 2024-05-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2175-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-17
Posted: 2024-06-24
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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 tag: design
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2175-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2175-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-24
Z-2176-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-24

Product code GEI

K101274Class IIVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC / cleared 2010-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)