The Recall Desk

Manufacturer

Atrium Medical Corporation

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

What the numbers show

Total
153
Critical
2
Severe
4
Most recent
2026-09-16

Of the 153 recalls from Atrium Medical Corporation we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (3%) are Severe.

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.

1–25 of 153

  • HighFDA (Devices)·Z-3112-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical is recalling specific lots of Getinge PVC Thoracic Catheters because one lot failed bacterial endotoxin testing.

    Product
    Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3113-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical Corporation is recalling specific lots of Getinge PVC Thoracic Catheters because bacterial endotoxin testing results were out of specification.

    Product
    Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3111-2026·2026-09-16

    Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing

    Atrium Medical Corporation is recalling specific lots of Getinge PVC Thoracic Catheters because an out-of-specification result was found in bacterial endotoxin testing.

    Product
    Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2025·2024-10-16

    iCast Covered Stent Recalled for Unique Device Identifier Labeling Error

    Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.

    Product
    iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2024·2024-06-12

    Vascular graft devices recalled due to slider component separation

    Atrium Medical is recalling ADVANTA VXT vascular grafts following complaints of separation between the slider component and swivel core.

    Product
    ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2024·2024-06-12

    Vascular graft component separation: Atrium Medical ADVANTA VXT recall

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.

    Product
    ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2024·2024-06-12

    Vascular Graft Component Separation Risk in ADVANTA VXT Models

    Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.

    Product
    ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2024·2024-06-12

    Vascular Graft Swivel Rod Separation Reported in ADVANTA VXT Devices

    Atrium Medical recalls ADVANTA VXT vascular grafts due to reported separation of the slider swivel rod from its core, creating a gap between components. No injuries reported.

    Product
    ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2024·2024-06-12

    Vascular graft component separation reported in Advanta VXT devices

    Atrium Medical Corporation recalls Advanta VXT vascular grafts due to separation of internal swivel components. Approximately 53,308 units worldwide are affected, with the slider GDS swivel rod potentially separating from its core.

    Product
    ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2024·2024-06-12

    Vascular graft component separation reported in ADVANTA VXT devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. No injuries have been reported.

    Product
    ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ATRIUM MEDICAL CORPORATION

Source: Wikidata (Q139903018), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.