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…
Read the official notice →- Date
- 2025-04-30
- Country
- United States
- Brand
- Maquet Cardiovascular
- Product
- The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Mexico, United…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
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
- 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 → - 2025-04-23
- 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 →
Other drugs & medical recalls in the United States
- 2025-04-30
- US
Merit Medical Systems, Inc. recalls Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
CareFusion 303, Inc. recalls BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI…
Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution including in the states of MO, MI, FL, PA, SC, OR,…Official notice → - US
Medtronic Xomed, Inc. recalls NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF;…
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
FDA · DeviceMedtronic Xomed, Inc.Worldwide - US Nationwide distribution including in the states of MD, MN, PA,…Official notice → - US
Conavi Medical Inc. recalls Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common…
Due to manufacturing issues there is a potential for the catheter sheath to detach.
FDA · DeviceConavi Medical Inc.US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries…Official notice → - US
Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as…
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- US
Philips North America Llc recalls Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional…
A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.