The Recall Desk

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.

51–75 of 86

  • HighFDA (Devices)·Z-2013-2024·2024-06-12

    FDA Recalls FLIXENE Vascular Graft Devices for Component Separation

    Atrium Medical Corporation recalls FLIXENE vascular graft devices due to reported separation of the Slider GDS Swivel Rod from its core, which could affect device function.

    Product
    FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2024·2024-06-12

    Vascular Graft Recalled Due to Potential Component Separation Risk

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units have been distributed worldwide.

    Product
    ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2024·2024-06-12

    Vascular Graft Component Separation Recall - Atrium Medical ADVANTA VXT

    Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft due to reported separation of the Swivel Rod from the Swivel Core. The component separation poses a risk of device failure.

    Product
    ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2024·2024-06-12

    Vascular graft separation defect recalled by Atrium Medical

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of internal components. The defect affects over 53,000 units distributed worldwide.

    Product
    ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2024·2024-06-12

    Vascular Graft Device Recalled for Slider Component Separation

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider component from the swivel core. The recall affects 53,308 units worldwide.

    Product
    ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2024·2024-06-12

    ADVANTA VXT Vascular Graft Recalled for Swivel Rod Separation Risk

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts after reports of separation between the Slider GDS Swivel Rod and Swivel Core. This structural defect could affect device performance.

    Product
    ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2024·2024-06-12

    Vascular graft recalled for swivel rod separation risk

    FDA recalls Atrium Medical's FLIXENE vascular grafts due to reports of the swivel rod separating from the core, potentially compromising device integrity.

    Product
    FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2024·2024-06-12

    Vascular Graft Component Separation Recall: ADVANTA VXT Slider

    Atrium Medical recalls ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. The defect affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2024·2024-06-12

    FDA Recalls ADVANTA VXT Vascular Grafts Due to Component Separation

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts because the Slider GDS Swivel Rod may separate from the Swivel Core. A total of 53,308 units are affected.

    Product
    ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2024·2024-06-12

    Vascular graft devices subject to swivel rod separation from core assembly

    Atrium Medical Corporation is recalling ADVANTA VXT vascular graft devices due to reports of the swivel rod separating from the core. The separation could compromise device function.

    Product
    ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2024·2024-06-12

    Vascular graft recalled for reported swivel rod separation from core

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of the swivel rod separating from the swivel core. Patients and healthcare providers should contact the manufacturer for guidance.

    Product
    ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2024·2024-06-12

    Vascular graft recall due to slider mechanism separation defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider mechanism. The defect affects over 53,000 units distributed worldwide and could compromise graft function.

    Product
    ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2024·2024-06-12

    FLIXENE Vascular Graft Recall for Swivel Rod Component Separation

    Atrium Medical is recalling FLIXENE vascular grafts due to complaints of separation between the Swivel Rod and Swivel Core components. The recall affects 53,308 units worldwide, including 11,236 in the US.

    Product
    FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2012-2024·2024-06-12

    Vascular Graft Swivel Component Separation Recall Affects Thousands Nationwide

    FDA recalls FLIXENE vascular grafts after complaints that the swivel rod separates from the swivel core. The defect affects over 53,000 units distributed worldwide.

    Product
    FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2024·2024-06-12

    Vascular graft recall: Advanta VXT swivel rod separation

    Atrium Medical recalls Advanta VXT vascular grafts due to swivel rod separation from the core component. Approximately 53,308 units are affected worldwide.

    Product
    ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2024·2024-06-12

    ADVANTA VXT vascular graft recalled for swivel rod separation

    Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of swivel rod separation from the swivel core. Affected units distributed worldwide; healthcare providers should evaluate appropriate management.

    Product
    ADVANTA VXT, 6X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2024·2024-06-12

    Vascular graft device recalled due to swivel rod separation

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect could compromise device function.

    Product
    FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2024·2024-06-12

    Vascular graft separation risk affects FLIXENE slider GDS devices

    Atrium Medical recalls FLIXENE vascular grafts due to complaints of slider rod separation from the swivel core, which could affect device function.

    Product
    FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2024·2024-06-12

    FDA Recalls Atrium Medical Vascular Graft for Slider Separation Defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider rod separating from the swivel core, which could impair proper device function.

    Product
    ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2024·2024-01-03

    Atrium Oasis surgical drain recalled for premature sterilization expiration

    Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.

    Product
    Atrium Oasis Drain Single W / AC, Part No. 3600-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2024·2023-12-13

    Atrium Oasis Chest Drain Recalled Due to Invalid Sterilization Process

    Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drains that were re-sterilized by a third party using unapproved methods and packaging. The invalid sterilization process lacks manufacturer validation and may compromise device sterility.

    Product
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0484-2024·2023-12-13

    Atrium Firm PVC Thoracic Catheter Recalled for Sterilization Nonconformance

    Atrium Medical Corporation is recalling 2,460 units of the Atrium Firm PVC Thoracic Catheter 36FR Straight due to sterilization nonconformance that caused premature product aging and inaccurate expiration dating. Facilities in 14 U.S. states are affected.

    Product
    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0486-2024·2023-12-13

    Chest Drain Devices Re-sterilized Using Unapproved Process

    Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.

    Product
    Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0291-2024·2023-11-22

    Atrium Advanta V12 Covered Stent System Recalled for Weld Failure

    Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.

    Product
    Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indicat
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0316-2024·2023-11-22

    Ocean Chest Drains Recalled for Inadequate Assembly Instructions

    Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.

    Product
    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,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ;
    Category
    Medical Device
    Distribution
    Distributed nationwide