Recent FDA Action: Three Recalls and Ten Medical Device Approvals

By MedTech Intelligence Staff

The device approvals address critical patient need.

FDA recently released a list of medical devices it has approved and recalled over the past few months. All of the recalls were Class I recalls.

Device Approvals

Device: Valiant Navion Thoracic Stent Graft System (Prosthetic endovascular graft)
Manufacturer: Medtronic Vascular
Inserted through a small cut in the groin, the implantable stent graft is used to repair lesions (i.e., aneurysms, transections, and dissections) in the descending thoracic aorta.

Device: GORE Carotid Stent
Manufacturer: W. L. Gore & Associates, Inc.
The nitinol stent is used to re-open narrowed regions of carotid arteries in the neck.

Device: INCRAFT AAA Stent Graft System
Manufacturer: Cordis Corp. (A Cardinal Health Company)
The multi-component stent graft system repairs a weakened and bulging section of the aorta below the renal arteries.

Device: Cardiva VASCADE MVP Venous Vascular Closure System
Manufacturer: Cardiva Medical, Inc.
The system is intended to close puncture sites in the femoral vein after catheterization procedures.

Device: Pipeline Flex Embolization Device
Manufacturer: Micro Therapeutics, Inc. , ev3 Neurovascular
Composed of platinum, tungsten and cobalt-chromium-nickel alloy wires, the permanent mesh stent treats brain aneurysms that bulge or balloon out the sides of the blood vessel.

Device: Resolute Onyx Zotarolimus Eluting Coronary Stent System
Manufacturer: Medtronic, Inc.
The drug-coated device consists of a stent and a catheter delivery system with a balloon, which inflates and deploys the stent into the coronary artery to keep it open.

Device: LIFEPAK CR2 Defibrillator
Manufacturer: Physio-Control, Inc.
This portable, battery-operated public-accessible defibrillator is designed to treat people experiencing sudden cardiac arrest.

Device: Woven EndoBridge Aneurysm Embolization System
Manufacturer: Sequent Medical, Inc.
The device is a permanent nitinol self-expanding mesh ball implant that is intended to treat wide-neck intracranial aneurysms located at or near branching areas of arteries in the brain.

Device: Zenith Dissection Endovascular System
Manufacturer: Cook, Inc.
This endovascular system is designed to treat patients with a tear in the inside lining of the descending thoracic aorta, which enables bloodflow between the layers of the aortic wall.

Device: Spiration Valve System
Manufacturer: Spiration, Inc.
The implantable nitinol bronchial valve and delivery system is used to reduce over-inflation of the lungs in adults with severe emphysema.

Recent Recalls

Device: VentStar and ID Breathing Circuits and Anesthesia Sets
Manufacturer: Draeger Medical, Inc.
Recalled Devices: 1200
Issue: Risk of devices being incorrectly assembled, which can cause a short-circuit in the breathing hose. This could lead to a patient not receiving ventilation, potentially causing hypoxia and death.

Device: Vial2Bag Direct Connect (DC) 13mm and 20mm, & Vial2Bag fluid transfer systems
Manufacturer: West Pharmaceutical Services, Inc.
Recalled Devices: 38.8 million (United States)
Issue: The device may not adequately transfer concentrated medication from a vial to an IV bag before infusion into a patient’s vein. Inadequate dosing can result in either an overdose or under-dose of medication, both of which can be life threatening.

Device: Roche Diagnostics CoaguChek XS PT Test Strips
Companies Initiating Recall: Terrific Care, LLC. or Medex Supply
Recall Count: 759 boxes
Issue: Inaccurate INR test results compared to lab results. The test strips are used to monitor Warfarin, thus inaccurate results can result in an incorrect dose of warfarin.

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