Maquet 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…
Read the official notice →- Date
- 2025-09-24
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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- Check the product name, strength and lot number against the official notice.
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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
- 2026-07-22
USMaquet Cardiovascular, LLC recalls The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II…
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.Official notice →- 2025-10-01
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Maquet Cardiovascular, LLC recalls Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH)…
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft,…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of FL, IL, MD & TX.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 → - 2025-01-15
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Maquet Cardiovascular, LLC recalls VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery…
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FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Australia, Austria,…Official notice → - 2024-11-27
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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.
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Other drugs & medical recalls in the United States
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- 2025-09-24
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C.R. Bard Inc recalls SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
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FDA · DeviceC.R. Bard IncUS Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX,…Official notice → - US
Abbott Point Of Care Inc. recalls i-STAT EG6+ cartridge. List Number: 03P77-25.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
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Abbott Point Of Care Inc. recalls i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
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Folsom Metal Products, Inc. recalls Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
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