Maquet Cardiovascular, LLC

Complete recall history across all FDA and CPSC categories — 251 total recalls

Maquet Cardiovascular, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (251)

FDA medical device enforcement actions by Maquet Cardiovascular, LLC. Showing most recent 50.

Date Product Reason Class
Aug 15, 2025 Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occlu... Three failure modes have been identified: failure of the Heartstring Seal to ... Class II
Aug 15, 2025 Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occlu... Three failure modes have been identified: failure of the Heartstring Seal to ... Class II
Aug 15, 2025 Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Three failure modes have been identified: failure of the Heartstring Seal to ... Class II
Aug 6, 2025 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ... Reports of out-of-box failures discovered during the limited launch phase. Fa... Class II
Mar 20, 2025 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... There have been at least 12 complaints from users as of March 3, 2025, report... Class II
Mar 10, 2025 Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of ... Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the ... Class II
Dec 9, 2024 Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model ... Potential for two issues: 1. Bent or detached heater wire; 2. Silicone pee... Class I
Dec 9, 2024 VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-400... Potential for two issues: 1. Bent or detached heater wire; 2. Silicone pee... Class I
Oct 16, 2024 Acrobat-i Positioner. Model Number C-XP-5000Z Deviations in the manufacturing process created a compromise in the sterile b... Class II
Oct 16, 2024 Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z Deviations in the manufacturing process created a compromise in the sterile b... Class II
Oct 16, 2024 Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z Deviations in the manufacturing process created a compromise in the sterile b... Class II
Sep 20, 2024 VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W... There were reports of the silicone detaching from the Jaws of the Harvesting ... Class I
May 31, 2024 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for us... There were 27 complaints between March 22, 2024, and April 30, 2024, related ... Class II
May 31, 2024 The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use... There were 27 complaints between March 22, 2024, and April 30, 2024, related ... Class II
May 17, 2024 The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for us... Potential for there to be a fluid ingress into the handle of the harvesting t... Class II
May 17, 2024 The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the fo... Potential for there to be a fluid ingress into the handle of the harvesting t... Class II
Dec 13, 2023 Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Express chest drains are pre-packaged with sterile water syringes which have ... Class I
Dec 13, 2023 Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Express chest drains are pre-packaged with sterile water syringes which have ... Class I
Dec 1, 2023 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. Risk of polyimide particulate matter being present on the endoscopic harvesti... Class II
Dec 1, 2023 Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . Risk of polyimide particulate matter being present on the endoscopic harvesti... Class II
Oct 31, 2023 Acrobat-i Vacuum Positioner System, Model Number XP-5000Z The Positioner Arm may not tighten or lock during normal use. Class II
Sep 19, 2023 Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri... Device packaged inside an incorrect outer box; displaying artwork & illustrat... Class II
Sep 13, 2023 Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance... Housing Mount Jaw of these devices breaking during normal use and may result ... Class II
Jun 28, 2023 ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a ches... The Standard Blade may not securely latch onto the Activator Drive. This may ... Class II
Jun 28, 2023 ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a ch... The Standard Blade may not securely latch onto the Activator Drive. This may ... Class II
Jun 28, 2023 ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) P... The Standard Blade may not securely latch onto the Activator Drive. This may ... Class II
Jun 28, 2023 ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a c... The Standard Blade may not securely latch onto the Activator Drive. This may ... Class II
Mar 6, 2023 VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 Some batches of product were not sterilized to their minimum sterilization sp... Class II
Mar 6, 2023 VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH... Some batches of product were not sterilized to their minimum sterilization sp... Class II
Mar 6, 2023 VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 Some batches of product were not sterilized to their minimum sterilization sp... Class II
Jan 30, 2023 Fusion Bioline Vascular Graft, Part number M00201503046B0 One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideli... Class II
Dec 22, 2022 Hemopro 2 with Vasoshield, Model VH-4001 Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonab... Class II
Dec 22, 2022 Vasoshield Syringe Packs, Model VH-5001 Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonab... Class II
Apr 29, 2022 INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovin... Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30... Class II
Feb 9, 2022 Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF ... Potential for corrosion on the pins of the Ultima Activator II Reusable Drive... Class II
Jan 14, 2022 HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6... Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Va... Class II
Dec 1, 2021 Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 There is a probable mislabeling of product. A Hemashield Platinum Woven Doub... Class II
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-... Class II

View all 251 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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