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VasoView HemoPro 2 Endoscopic Vessel Harvesting System.… recallZ-0711-2025 · Maquet Cardiovascular, LLC · initiated Dec 9, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0711-2025
Status
Open, Classified
Initiated by the company
Dec 9, 2024
Posted by the FDA
Jan 3, 2025
Recalling firm
Maquet Cardiovascular, LLC
Quantity
418,076 units (326,608 US, 91,468 OUS)
Product code
GEI
FDA submissions
K101274
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 description

VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Code information (models, lots, serial numbers)

Model Number: VH-4000. UDI-DI: 00607567700406. All unexpired Lots.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K101274 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95908).

Sources and updates

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