Recall archive
31 recalls · page 1 of 2
Reported Jul 22, 2026
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma…
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the…
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand · Product · Product details — Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
Matched: Brand — Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Acrobat-i Positioner. Model Number C-XP-5000Z
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
Matched: Brand — There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
FDA (openFDA device enforcement)
Reported Jul 17, 2024
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
Matched: Brand — Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — The Positioner Arm may not tighten or lock during normal use.
FDA (openFDA device enforcement)
Reported Nov 8, 2023
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand · Product · Product details — Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery…
FDA (openFDA device enforcement)
Reported Aug 9, 2023
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 12, 2023
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Some batches of product were not sterilized to their minimum sterilization specification.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Fusion Bioline Vascular Graft, Part number M00201503046B0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and…
FDA (openFDA device enforcement)
Reported Jan 25, 2023
Hemopro 2 with Vasoshield, Model VH-4001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand · Reason for recall — Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 29, 2022
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32…
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and…
FDA (openFDA device enforcement)
Reported Mar 16, 2022
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner)…
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF…
FDA (openFDA device enforcement)
Reported May 13, 2020
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand — Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
23 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2019
Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
Matched: Brand · Product · Product details — Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow…
182 more products in this recall
FDA (openFDA device enforcement)
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