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Atrium Medical Corporation Recalls

105 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Atrium Medical Corporation.

105Total Recalls
3Critical
10.3MUnits Affected
Sep 9, 2024Most Recent
All Recalls

Every Atrium Medical Corporation Recall

Sorted by most recent. Click any recall for full details.

105 recalls
High RiskFDA
Atrium Medical Corporation
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Surgical Devices·2,460 affected·Sep 29, 2023
High RiskFDA
Atrium Medical Corporation
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Medical Devices·48,339 affected·Sep 18, 2023
High RiskFDA
Atrium Medical Corporation
Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, O...
Medical Devices·31,270 affected·Sep 18, 2023
High RiskFDA
Atrium Medical Corporation
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)3650-10...
Medical Devices·471,037 affected·Sep 18, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Medical Devices·0 affected·Sep 5, 2023
High RiskFDA
Atrium Medical Corporation
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Medical Devices·8,184 affected·Mar 1, 2023
CriticalFDA
Atrium Medical Corporation
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 8...
Medical Implants·105,968 affected·Mar 3, 2022
CriticalFDA
Atrium Medical Corporation
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 854...
Medical Implants·68,812 affected·Mar 3, 2022
High RiskFDA
Atrium Medical Corporation
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed...
Medical Devices·87,972 affected·Oct 22, 2021
CriticalFDA
Atrium Medical Corporation
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Medical Devices·92,430 affected·Aug 26, 2021
High RiskFDA
Atrium Medical Corporation
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstructi...
Medical Devices·28 affected·Aug 25, 2021
High RiskFDA
Atrium Medical Corporation
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Surgical Devices·2,930 affected·Oct 12, 2018
High RiskFDA
Atrium Medical Corporation
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12...
Medical Implants·246 affected·May 25, 2017
High RiskFDA
Atrium Medical Corporation
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
Surgical Devices·660 affected·Jan 20, 2017
High RiskFDA
Atrium Medical Corporation
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavi...
Medical Devices·1 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the c...
Medical Devices·27 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid ...
Medical Devices·2,933 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the ch...
Medical Devices·245 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the che...
Medical Devices·3 affected·Dec 23, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Expre...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Pa...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and P...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-l...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction con...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Oc...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control s...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavi...
Surgical Devices·2,172 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the...
Surgical Devices·5,055 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the ...
Surgical Devices·4,836 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the c...
Surgical Devices·1,617 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Surgical Devices·62 affected·Jun 19, 2015
High RiskFDA
Atrium Medical Corporation
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
Medical Devices·1,170 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050...
Medical Devices·10,448 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100...
Medical Devices·954 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors...
Medical Devices·361 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-...
Medical Devices·42,699 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P...
Medical Devices·1,944 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-3...
Medical Devices·1,002 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-3...
Medical Devices·6,684 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or flu...
Medical Devices·7,274 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Medical Devices·1,501 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Medical Devices·95,286 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Medical Devices·32,834 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013