Maquet Cardiovascular recalls
23 official recalls and safety alerts involving Maquet Cardiovascular since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Maquet Cardiovascular or the relevant agency.
- 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
- US
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 → - 2025-09-24
- US
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…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2025-04-30
- US
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
- US
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
- US
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
FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Australia, Austria,…Official notice → - 2024-11-27
- US
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 → - 2024-07-03
- US
Maquet Cardiovascular, LLC recalls The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2.…
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 intended.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Australia Brazil,…Official notice → - 2024-01-24
- US
Maquet Cardiovascular, LLC recalls Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a…
- US
Maquet Cardiovascular, LLC recalls Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
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 to infectious material. Subsequent hazards…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice → - 2023-12-27
- US
Maquet Cardiovascular, LLC recalls Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
The Positioner Arm may not tighten or lock during normal use.
- 2023-11-08
- US
Maquet Cardiovascular, LLC recalls Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box…
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
FDA · DeviceMaquet Cardiovascular, LLCUS (AL, AR, CA, FL, GA, IN, KY, MI, NJ, OK, PA, TN, TX) and Canada.Official notice → - 2023-11-01
- US
Maquet Cardiovascular, LLC recalls Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy…
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 bypass graft, or could result in procedural…
FDA · DeviceMaquet Cardiovascular, LLCNationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TROfficial notice → - 2023-08-09
- US
Maquet Cardiovascular, LLC recalls ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
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 and positioning of heart, release of device…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Bangladesh,…Official notice → - 2023-04-12
- US
Maquet Cardiovascular, LLC recalls VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Some batches of product were not sterilized to their minimum sterilization specification.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution - US Nationwide and the countries of Brazil, China.Official notice → - 2023-03-22
- US
Maquet Cardiovascular, LLC recalls Fusion Bioline Vascular Graft, Part number M00201503046B0
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY,…Official notice → - 2023-01-25
- US
Maquet Cardiovascular, LLC recalls Vasoshield Syringe Packs, Model VH-5001
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 embolic event, and peripheral embolic event.
- 2022-06-29
- US
Maquet Cardiovascular, LLC recalls INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and…
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
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the state of SC.Official notice → - 2022-04-13
- US
Maquet Cardiovascular, LLC recalls Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
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.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX,…Official notice → - 2022-03-16
- US
Maquet Cardiovascular, LLC recalls HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of…
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 labelling (HEMASHIELD GOLD Knitted Microvel Double…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the state of MO.Official notice → - 2021-12-29
- US
Maquet Cardiovascular, LLC recalls Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
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 is likely packaged inside of the carton instead…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of IL and NC.Official notice →