Manufacturer

Atrium Medical Corporation

86 recalls in our database name Atrium Medical Corporation as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–86 of 86

HighFDA (Devices)·Z-0317-2024·2023-11-22
Oasis Water Seal Chest Drains Recalled for Inadequate Setup Instructions
Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.
Product
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, OASIS BRU W/AC;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0318-2024·2023-11-22
Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions
Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.
Product
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2023·2023-04-05
Chest Drain Valve Recalled for Insufficient Safety Instructions
The Atrium Pneumostat Chest Drain Valve has been recalled because its instructions lack sufficient precautions against improper drainage and use outside healthcare settings.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2023·2023-04-05
Express Mini 500 Chest Drain Recalled for Inadequate Instructions
The Express Mini 500 Dry Seal Chest Drain has been recalled because its instructions do not adequately warn against draining it for continued use or using it outside healthcare settings. Approximately 8,184 cases were distributed worldwide.
Product
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0235-2023·2022-11-23
Atrium Ocean Wet Suction Chest Drains recalled due to storage temperature excursions
Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.
Product
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1297-2022·2022-07-06
Atrium Firm PVC Thoracic Catheter Recall Due to Expiration Date Mismatch
Atrium Medical Corporation is recalling Atrium Firm PVC Thoracic Catheter 28French due to an expiration date mismatch between the sterile barrier pouch and case labels. The discrepancy allowed product to be used up to five days past its true expiration date.
Product
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
Category
Medical Device
Distribution
10 states
CriticalFDA (Devices)·Z-1077-2022·2022-05-25
FDA Recalls iCast Covered Stent System Due to Device Separation During Delivery
Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.
Product
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1076-2022·2022-05-25
Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation
Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.
Product
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0307-2022·2021-12-01
Ocean Water Seal Chest Drain Recalled for Inadequate Setup Instructions
Atrium Medical is recalling 87,972 Ocean Water Seal Chest Drains due to inadequate setup instructions that may result in treatment delays and risk of patient harm.
Product
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chambe
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2592-2021·2021-10-06
Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2589-2021·2021-10-06
Atrium ADVANTA VXT Vascular Graft may lack required radial support ring
Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft because some packages may contain mismatched units lacking the radial support ring specified in labeling.
Product
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide