FDA Device Recalls

Recalls / Firms / Atrium Medical Corporation

Atrium Medical Corporation

177 FDA device recalls on record.

DateClassProductReason
2024-09-09iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
2024-05-03ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2024-05-03ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
2024-05-03ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
2023-11-01Atrium Oasis Drain Single W / AC, Part No. 3600-100
2023-09-29Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
2023-09-21Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and impro
2023-09-18Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SI
2023-09-18Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100
2023-09-18Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS
2023-09-05Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 36
2023-09-05Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650
2023-03-01Atrium Pneumostat Chest Drain Valve, Part Number 16100
2023-03-01Express Mini 500 Dry Seal Chest Drain, Part Number 16400
2022-10-18Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
2022-04-21Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid
2022-03-03iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 8540
2022-03-03Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 853
2021-10-22The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of
2021-08-26Atrium Pneumostat Chest Drain Valve, Part Number 16100
2021-08-25Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for
2018-10-12Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
2017-11-22ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficienci
2017-05-25Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Markete
2017-01-20Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
2017-01-20Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
2016-12-23Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Us
2016-12-23Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended
2016-12-23Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate a
2016-12-23Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuat
2016-12-23Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To eva
2016-12-23Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To ev
2016-12-23Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To eva
2016-11-29Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and su
2016-11-29Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, wi
2016-11-29Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line
2016-11-29Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connector
2016-11-29Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-l
2016-11-29Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid fro
2016-11-29Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-
2016-11-29Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with
2016-11-29Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 36
2016-11-29Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product
2016-10-26Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacua
2016-10-26Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evac
2016-10-26Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacu
2016-10-26Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacua
2016-10-26Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of ai
2016-10-26Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuat
2016-10-26Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuat
2016-10-26Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuat
2015-06-19Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
2015-05-07Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
2015-05-07Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
2015-05-07EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
2015-05-07Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
2014-04-28Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion
2013-11-19Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines
2013-11-19Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air L
2013-11-19Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors
2013-11-19Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood
2013-11-19Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in
2013-11-19Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and i
2013-11-19Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 405
2013-11-19Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines
2013-11-19Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual p
2013-07-19C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
2013-07-19C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
2013-07-19C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
2013-07-19C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
2013-07-16PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist
2013-07-12Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vasc
2013-07-12Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and
2013-07-12Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass,
2013-07-12Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and
2013-07-12Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and
2013-07-12Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental
2013-07-12Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segment
2013-07-12Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass
2013-07-12Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, a
2013-07-12Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and f
2013-07-12Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental
2013-07-12Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental by
2013-07-12Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental
2013-07-12Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and
2010-08-10HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
2010-08-10HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14120, Size (Fr) 20,
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14132, Size (Fr) 32,
2008-05-12HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code
2008-05-12HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets, Increased Len
2008-05-12HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code
2008-05-12ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408, Size (Fr) 8, # Eyelets 2, 1
2008-05-12HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428, Size (Fr) 28, # Eyelets 2,
2008-05-12HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code
2008-05-12HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets, Increased Len
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top & Bottom, Atrium Co
2008-05-12HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code #
2008-05-12ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2,
2008-05-12HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14124, Size (Fr) 24,
2008-05-12HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, Atrium Code # 1470
2006-11-08Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N