Recall archive
26 recalls · page 1 of 2
Reported Sep 16, 2026
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
2 more products in this recall
FDA (weekly enforcement report)
Reported Oct 16, 2024
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
67 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 4, 2024
Getinge/Atrium Medical Corporation recalls Atrium Express Drains due to Syringes provided with Express Drains could not be verified to be sterile.
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Getinge/Atrium Medical Corporation
Matched: Brand · Product · Product details — Syringes provided with Express Drains could not be verified to be sterile.
FDA (recalls & safety alerts)
Reported Jan 3, 2024
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This…
FDA (openFDA device enforcement)
Reported Dec 13, 2023
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2023
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch…
FDA (openFDA device enforcement)
Reported May 25, 2022
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Atrium Medical Corporation
Matched: Brand · Product · Product details — Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
FDA (openFDA device enforcement)
Reported Oct 6, 2021
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 12, 2018
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details · Reason for recall — This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are…
FDA (openFDA device enforcement)
Reported Mar 7, 2018
ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code…
FDA (openFDA device enforcement)
Reported Aug 2, 2017
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the…
FDA (openFDA device enforcement)
Reported Feb 22, 2017
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2017
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Outer Packaging is not sterile
9 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 23, 2016
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2015
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — Chest drains have a missing o-ring
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2014
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution…
FDA (openFDA device enforcement)
Reported Jan 22, 2014
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand · Product · Product details — Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
8 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2013
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
Matched: Brand — Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
13 more products in this recall
FDA (openFDA device enforcement)
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