PlainRecalls

Atrium Medical Corporation

Compiled from official public sources by the editorial team.

150 recalls on record · Latest: Oct 16, 2024

Atrium Medical Corporation Recall Insight

Atrium Medical Corporation appears on 150 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.147% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 16, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 2 critical, 48 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 48 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Feb 1, 2017 to Jun 12, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

FDA Devices Moderate Jun 12, 2024

FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

FDA Devices Moderate Jun 12, 2024

ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

FDA Devices Moderate Jan 3, 2024

Atrium Oasis Drain Single W / AC, Part No. 3600-100

FDA Devices Moderate Dec 13, 2023

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

FDA Devices Moderate Dec 13, 2023

Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.

FDA Devices Moderate Dec 13, 2023

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

FDA Devices Moderate Nov 22, 2023

Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

FDA Devices Moderate Nov 22, 2023

Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,…

FDA Devices Moderate Nov 22, 2023

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, OAS…

FDA Devices Moderate Nov 22, 2023

Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. …

FDA Devices Moderate Apr 5, 2023

Express Mini 500 Dry Seal Chest Drain, Part Number 16400

FDA Devices Moderate Apr 5, 2023

Atrium Pneumostat Chest Drain Valve, Part Number 16100

FDA Devices Moderate Nov 23, 2022

Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

FDA Devices Moderate Jul 6, 2022

Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product R…

FDA Devices Critical May 25, 2022

Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 8…

FDA Devices Critical May 25, 2022

iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 8…

FDA Devices Moderate Dec 1, 2021

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal…

FDA Devices Moderate Oct 6, 2021

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmenta…

FDA Devices Moderate Oct 6, 2021

Atrium Pneumostat Chest Drain Valve, Part Number 16100

FDA Devices Moderate Dec 12, 2018

Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

FDA Devices Moderate Mar 7, 2018

ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgic…

FDA Devices Moderate Aug 2, 2017

Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Exp…

FDA Devices Moderate Feb 22, 2017

Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or medias…

FDA Devices Moderate Feb 22, 2017

Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008

FDA Devices Moderate Feb 22, 2017

Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity …

FDA Devices Moderate Feb 22, 2017

Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the che…

FDA Devices Moderate Feb 22, 2017

Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity o…

FDA Devices Moderate Feb 22, 2017

Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or…

FDA Devices Moderate Feb 22, 2017

Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

FDA Devices Moderate Feb 22, 2017

Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or med…

FDA Devices Moderate Feb 22, 2017

Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest …

FDA Devices Moderate Feb 1, 2017

Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled…

FDA Devices Moderate Feb 1, 2017

Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes)…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.