FDA recall record · openFDA
Atrium Medical Corporation
79 FDA recalls on record (2023–2024) — 79 device. 79 still ongoing.
0
Class I (most serious)
79
Class II
0
Class III
79
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two 68
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution in 3
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process w 2
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do no 2
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label 1
Recalls
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 Class II 2024-09-09 ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 5X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft Class II 2024-05-03 FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft Class II 2024-05-03 ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft Class II 2024-05-03 Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU Class II 2023-09-18 Atrium Oasis Drain Single W / AC, Part No. 3600-100 Class II 2023-11-01 Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY Class II 2023-09-05 Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION Class II 2023-09-05 Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. Class II 2023-09-29 Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2) Class II 2023-09-18 Express Mini 500 Dry Seal Chest Drain, Part Number 16400 Class II 2023-03-01 Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI Class II 2023-09-18 Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of Class II 2023-09-21 Atrium Pneumostat Chest Drain Valve, Part Number 16100 Class II 2023-03-01
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.