Z-0712-2025Class I

Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for...

Name: Z-0712-2025 Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for...
Creator: Maquet Cardiovascular, LLC
Published: 2024-12-09
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2024-12-09 / Open, Classified / root cause: design

FDA source

Maquet Cardiovascular, LLC began a recall of Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access... on 2024-12-09. FDA classified it as Class I and gives the reason as "Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool". 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-0712-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-09
Posted: 2025-01-03
Recalling firm: Maquet Cardiovascular LLC
Product: Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Root cause tag: design
FDA root cause: Device Design
Action: Getinge notified consignees on 12/09/2024 via Urgent Medical Device Correction letter posted digitally on Getinge.com and sent to consignees via letter. Consignees were not instructed to return affected units, but instead to review the IFU information provided with the letter to minimize over-delivery of energy and mitigate risks. Getinge instructed consignees to notify customers if further distributed, as well as requested to complete and return the MEDICAL DEVICE CORRECTION RESPONSE FORM. Training to reinforce precautions and appropriate use of the device is expected to be deployed and communicated to all customers by end of January 2025. UPDATE: On 01/31/2025 an updated URGENT MEDICAL DEVICE CORRECTION letter was sent to customers. Consignees were instructed to review the IFU information provided in Appendix A of the letter and consider the listed areas to mitigate the risks. Getinge has created a training video, accessible via a QR code or link, to guide users on the proper use of the device and reinforce essential precautions. Consignees were instructed to notify customers if product was further distributed. Additionally, consignees were instructed to complete, sign and return the provided MEDICAL DEVICE CORRECTION RESPONSE FORM. 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 address the bent or detached heater wire and silicone peeling or detaching from the Jaws 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: 11,101 units US
Distribution: Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates.
Product codes and lots: Model Number: VH-4001. UDI-DI: 00607567700451. All unexpired Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0712-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0711-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-03
Z-0712-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-03

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)