Drugs & medicalClass II

Atrium Medical Corporation recalls ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Read the official notice →
Date
2024-06-12
Country
United States
Brand
Atrium Medical
Product
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Classification
Class II
Units
Worldwide distribution - US Nationwide including Puerto Rico, and the…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Atrium Medical recalls

  1. 2026-09-16
  2. US
    Drugs & medicalClass II

    Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4.…

    An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

    FDA · DeviceAtrium Medical CorporationUS Nationwide distribution.Official notice →
  3. 2024-10-16
  4. US
    Drugs & medicalClass II

    Atrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

    There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

    FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the states of FL, MA, MI, OH, WA.Official notice →
  5. 2024-01-03
  6. US
    Drugs & medicalClass II

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

    A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers.…

    FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. No foreign distribution.Official notice →
  7. 2023-12-13
  8. US
    Drugs & medicalClass II

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

    Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

    FDA · DeviceAtrium Medical CorporationUS: VAOfficial notice →
  9. US
    Drugs & medicalClass II

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

    A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.

    FDA · DeviceAtrium Medical CorporationUS: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TXOfficial notice →
  10. 2023-11-22
  11. US
    Drugs & medicalClass II

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

    Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection…

    FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice →
All 15 Atrium Medical recalls →

Other drugs & medical recalls in the United States

  1. 2024-06-12
  2. US
    Drugs & medicalClass II

    Becton Dickinson & Co. recalls BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and…

    Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.

    FDA · DeviceBecton Dickinson & Co.Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.Official notice →
  3. US
    Drugs & medicalClass II

    Verathon, Inc. recalls Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product…

    Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.

    FDA · DeviceVerathon, Inc.US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS…Official notice →
  4. US
    Drugs & medicalClass III

    Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration…

    The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the…

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide and the country of Columbia.Official notice →
  5. US
    Drugs & medicalClass II

    Philips North America Llc recalls HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number:…

    Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard

    FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  6. US
    Drugs & medicalClass II

    LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.

    Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.

    FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHWorldwide - US Nationwide distribution including in the states of AK, AL, AZ,…Official notice →
  7. US
    Drugs & medicalClass II

    Newport Corp recalls Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply…

    According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when…

    FDA · DeviceNewport CorpUS NationwideOfficial notice →
See all drugs & medical recalls →