Maquet Cardiovascular, LLC recalls
32 recalls in our records from 2013 to 2026: 32 FDA medical devices.
Recalls with full detail pages
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Maquet Cardiovascular, LLC medical device recall: VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model…
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Earlier and other recalls
These link to the official agency notice.
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Maquet Cardiovascular, LLC medical device recall: The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System Official notice ↗
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…
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Maquet Cardiovascular, LLC medical device recall: Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No.… Official notice ↗
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…
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Maquet Cardiovascular, LLC medical device recall: Heartstring III Proximal Seal System. Intravascular anastomosis… Official notice ↗
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…
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Maquet Cardiovascular, LLC medical device recall: The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is… Official notice ↗
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.…
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Maquet Cardiovascular, LLC medical device recall: Maquet VH-3010 Power Supply. Used to deliver power to the harvesting… Official notice ↗
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
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Maquet Cardiovascular, LLC medical device recall: Acrobat-i Positioner. Model Number C-XP-5000Z Official notice ↗
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…
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Maquet Cardiovascular, LLC medical device recall: VasoView HemoPro Endoscopic Vessel Harvesting System Official notice ↗
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
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Maquet Cardiovascular, LLC medical device recall: The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed… Official notice ↗
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…
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Maquet Cardiovascular, LLC medical device recall: The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System Official notice ↗
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…
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Maquet Cardiovascular, LLC medical device recall: Vasoview Hemopro Endoscopic Vessel Harvesting System Official notice ↗
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced…
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Maquet Cardiovascular, LLC medical device recall: Product REF 4000-100N Official notice ↗
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 patient may be exposed…
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Maquet Cardiovascular, LLC medical device recall: Acrobat-i Vacuum Positioner System Official notice ↗
The Positioner Arm may not tighten or lock during normal use.
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Maquet Cardiovascular, LLC medical device recall: Vasoview 6 Pro Official notice ↗
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
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Maquet Cardiovascular, LLC medical device recall: Maquet Acrobat-i Vacuum Stabilizer System Intended for use during… Official notice ↗
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 or previously placed…
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Maquet Cardiovascular, LLC medical device recall: ACCESSRAIL Platform Official notice ↗
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 loss of stabilization…
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Maquet Cardiovascular, LLC medical device recall: VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System Official notice ↗
Some batches of product were not sterilized to their minimum sterilization specification.
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Maquet Cardiovascular, LLC medical device recall: Fusion Bioline Vascular Graft Official notice ↗
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers.…
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Maquet Cardiovascular, LLC medical device recall: Hemopro 2 with Vasoshield Official notice ↗
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 reaction, coronary…
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Maquet Cardiovascular, LLC medical device recall: INTERGARD Woven Vascular Graft is a woven polyester graft coated with… Official notice ↗
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 mm and L: 30 cm
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Maquet Cardiovascular, LLC medical device recall: Ultima Activator II Reusable Drive Mechanism Official notice ↗
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
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Maquet Cardiovascular, LLC medical device recall: HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm Official notice ↗
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) sterile packaging…
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Maquet Cardiovascular, LLC medical device recall: Hemashield Gold Knitted Bifurcated Official notice ↗
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0…
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Maquet Cardiovascular, LLC medical device recall: Hemashield Gold Knitted Microvel Double Velour Vascular… Official notice ↗
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
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Maquet Cardiovascular, LLC medical device recall: Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087 Official notice ↗
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene…
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Maquet Cardiovascular, LLC medical device recall: AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower… Official notice ↗
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
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Maquet Cardiovascular, LLC medical device recall: VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product… Official notice ↗
Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
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Maquet Cardiovascular, LLC medical device recall: Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump… Official notice ↗
An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump…
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Maquet Cardiovascular, LLC medical device recall: Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet… Official notice ↗
Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
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Maquet Cardiovascular, LLC medical device recall: Ultima OPCAB System Official notice ↗
MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The…
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Maquet Cardiovascular, LLC medical device recall: MAQUET CARDIOHELP Support System: CARDIOHELP-I Software Official notice ↗
It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface…
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Maquet Cardiovascular, LLC medical device recall: CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used… Official notice ↗
In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.