Atrium Medical Corporation
111 recalls on record · Latest: Oct 16, 2024
FDA Devices Moderate Dec 13, 2023
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
FDA Devices Moderate Dec 13, 2023
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
FDA Devices Moderate Dec 13, 2023
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
FDA Devices Moderate Nov 22, 2023
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
FDA Devices Moderate Nov 22, 2023
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,…
FDA Devices Moderate Nov 22, 2023
Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OAS…
FDA Devices Moderate Nov 22, 2023
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. …
FDA Devices Moderate Apr 5, 2023
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
FDA Devices Critical May 25, 2022
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 8…
FDA Devices Critical May 25, 2022
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 8…
FDA Devices Moderate Dec 1, 2021
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal…
FDA Devices Moderate Oct 6, 2021
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmenta…
FDA Devices Moderate Oct 6, 2021
Atrium Pneumostat Chest Drain Valve, Part Number 16100
FDA Devices Moderate Dec 12, 2018
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
FDA Devices Moderate Aug 2, 2017
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Exp…
FDA Devices Moderate Feb 22, 2017
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or medias…
FDA Devices Moderate Feb 22, 2017
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
FDA Devices Moderate Feb 22, 2017
Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity …
FDA Devices Moderate Feb 22, 2017
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the che…
FDA Devices Moderate Feb 22, 2017
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity o…
FDA Devices Moderate Feb 22, 2017
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or…
FDA Devices Moderate Feb 1, 2017
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled…
FDA Devices Moderate Feb 1, 2017
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes)…
FDA Devices Moderate Feb 1, 2017
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connecto…
FDA Devices Moderate Feb 1, 2017
Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connecto…
FDA Devices Moderate Feb 1, 2017
Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcoc…
FDA Devices Moderate Feb 1, 2017
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single d…
FDA Devices Moderate Feb 1, 2017
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 20…
FDA Devices Moderate Nov 23, 2016
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or medias…
FDA Devices Moderate Nov 23, 2016
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavit…
FDA Devices Moderate Nov 23, 2016
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity…
FDA Devices Moderate Nov 23, 2016
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity …
FDA Devices Moderate Nov 23, 2016
Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity …
FDA Devices Moderate Aug 12, 2015
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
FDA Devices Moderate Jul 8, 2015
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Devices Moderate Jul 8, 2015
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA Devices Moderate Jul 8, 2015
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
FDA Devices Moderate Jan 22, 2014
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To …
FDA Devices Moderate Jan 22, 2014
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evac…
FDA Devices Moderate Jan 22, 2014
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Co…
FDA Devices Moderate Jan 22, 2014
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To e…
FDA Devices Moderate Jan 22, 2014
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To ev…
FDA Devices Moderate Jan 22, 2014
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To ev…
FDA Devices Moderate Jan 22, 2014
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To ev…
FDA Devices Moderate Jan 22, 2014
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the …
FDA Devices Moderate Oct 9, 2013
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Devices Moderate Oct 9, 2013
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Devices Moderate Oct 9, 2013
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Devices Moderate Oct 9, 2013
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Devices Moderate Oct 9, 2013