Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-07-03FDA-DeviceCenters For Disease Control and PreventionClass IICDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
The H5b component may fail to amplify, resulting in an inconclusive result.
- 2024-07-03FDA-DeviceStryker GmbHClass IIStryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
- 2024-07-03FDA-DeviceMerit Medical Systems, Inc.Class IIPrelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX -PG7F65SX -PG7F90SX -PG8F45MPX -PG8F45S -PG8F45SX -PG8F65SX -PG8F90SX -X9PG700001 The Prelude Guide Sheath Introducer is indicated to be used for the introduction of
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.
- 2024-07-03FDA-DeviceNovaSignal Corp.Class IINovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
- 2024-07-03FDA-DeviceNovaSignal Corp.Class IINovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CA
Due to inadvertently disconnecting grounding cable of ultrasound system could result in electrical shock, electrical interference and/or equipment malfunction.
- 2024-07-03FDA-DeviceThoratec Switzerland GMBHClass II2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
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.
- 2024-07-03FDA-DeviceSiemens Healthcare Diagnostics IncClass IISoftware version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Blood Gas System (ROW) 11416755 ;
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.
- 2024-07-03FDA-DeviceMermaid Medical A/SClass IIThe D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIProduct not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIMIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIMIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIPRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIMIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIMIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIPRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIEVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIEVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIEVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IIEVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceMedtronic Inc.Class IICOBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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