July 3, 2024Medical DevicesFDA
Centers For Disease Control and Prevention recalls CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
Hazard: The H5b component may fail to amplify, resulting in an inconclusive result.
July 3, 2024Medical DevicesFDA
Stryker GmbH recalls Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Hazard: The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
July 3, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S
Hazard: Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
July 3, 2024Medical DevicesFDA
NovaSignal Corp. recalls NovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Hazard: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
July 3, 2024Medical DevicesFDA
NovaSignal Corp. recalls NovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Hazard: Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
July 3, 2024Medical DevicesFDA
Thoratec Switzerland GMBH recalls 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-9
Hazard: Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
July 3, 2024Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e
Hazard: Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
July 3, 2024Medical DevicesFDA
Mermaid Medical A/S recalls The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The dispos
Hazard: Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTB
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.