Maquet Cardiovascular, LLC recalls VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
- Classification
- Class I
- Units
- Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Maquet Cardiovascular recalls
- 2025-04-23
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Maquet Cardiovascular, LLC recalls Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide - US Nationwide distribution in the states of AL, CA, CO, DC, FL,…Official notice →- 2025-01-15
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Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
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FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Albania, Algeria,…Official notice →- 2024-07-17
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Maquet Cardiovascular, LLC recalls The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope.…
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between…
FDA · DeviceMaquet Cardiovascular, LLCNationwideForeign: AT DE DK ES GB HK IT NL ZAOfficial notice →- 2024-07-03
US
Maquet Cardiovascular, LLC recalls The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2.…
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.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Australia Brazil,…Official notice →- 2024-01-24
US
Maquet Cardiovascular, LLC recalls Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a…
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