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Atrium Medical Recalls

150 recalls on record · August 21, 2013 to October 16, 2024 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

July 8, 2015Medical DevicesFDA
Atrium Medical Corporation recalls Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Hazard: Chest drains have a missing o-ring
July 9, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Hazard: Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacua
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Produc
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Pro
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Prod
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and i
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Pro
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
January 22, 2014Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; P
Hazard: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous v
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous v
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenou
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstructio
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous v
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriove
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arterioveno
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous v
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous va
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for art
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arter
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for ar
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
October 9, 2013Medical DevicesFDA
Atrium Medical Corporation recalls Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for ar
Hazard: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
August 28, 2013Medical DevicesFDA
Atrium Medical Corporation recalls PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion
Hazard: Individual component's IFUs are not included with the kit.
August 21, 2013Medical DevicesFDA
Atrium Medical Corporation recalls C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Hazard: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
August 21, 2013Medical DevicesFDA
Atrium Medical Corporation recalls C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Hazard: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
August 21, 2013Medical DevicesFDA
Atrium Medical Corporation recalls C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Hazard: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
August 21, 2013Medical DevicesFDA
Atrium Medical Corporation recalls C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Hazard: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions