Maquet Cardiovascular, LLC recalls VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery…
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Read the official notice →- Date
- 2025-01-15
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing…
- Classification
- Class I
- Units
- Nationwide distribution. International distribution to Australia, Austria,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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USMaquet Cardiovascular, LLC recalls Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2025-04-30
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Maquet Cardiovascular, LLC recalls The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length…
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Mexico, United…Official notice → - 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 → - 2024-11-27
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Maquet Cardiovascular, LLC recalls Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Albania, Algeria,…Official notice → - 2024-11-06
- US
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.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution. US Nationwide. Brazil, China, and Hong Kong.Official notice → - 2024-07-17
- US
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 →
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Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe
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FDA · DeviceFresenius Kabi USA, LLCUS distribution to states of: ID, MN, NV, TX, VA, WI.Official notice → - US
Granules Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India…
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
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Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only,…
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