Medical Device Recall Search

Recall Search

Medical Device Recall Search

Search live FDA recall data for medical devices. Enter a device type, brand name, or body area. Results come directly from the FDA's device recall database, updated continuously.

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846 results for “stent”

  • ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, …

    Recalling firm
    Endologix
    Status
    Terminated
    Date initiated
    2018-07-31
    Reason for recall
    Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

  • Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of…

    Recalling firm
    Bard Peripheral Vascular Inc
    Status
    Terminated
    Date initiated
    2013-09-30
    Reason for recall
    Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.

  • ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-…

    Recalling firm
    Endologix
    Status
    Terminated
    Date initiated
    2018-07-31
    Reason for recall
    Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

  • Biliary Stent System (6Fr 9mm x 30mm).

    Recalling firm
    Ev3
    Status
    Terminated
    Date initiated
    2004-09-01
    Reason for recall
    A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.

  • iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

    Recalling firm
    Atrium Medical Corporation
    Status
    Open, Classified
    Date initiated
    2024-09-09
    Reason for recall
    There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

  • Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system …

    Recalling firm
    Bard Peripheral Vascular Inc
    Status
    Terminated
    Date initiated
    2008-08-29
    Reason for recall
    Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.

  • Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system …

    Recalling firm
    Bard Peripheral Vascular Inc
    Status
    Terminated
    Date initiated
    2008-08-29
    Reason for recall
    Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.

  • Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system …

    Recalling firm
    Bard Peripheral Vascular Inc
    Status
    Terminated
    Date initiated
    2008-08-29
    Reason for recall
    Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.

  • Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001

    Recalling firm
    Hobbs Medical, Inc.
    Status
    Open, Classified
    Date initiated
    2022-07-29
    Reason for recall
    Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

  • Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060303CD. The LifeStent FlexStar self-expanding biliary stent system …

    Recalling firm
    Bard Peripheral Vascular Inc
    Status
    Terminated
    Date initiated
    2008-08-29
    Reason for recall
    Some LifeStent FlexStar Systems may exhibit a gap between the tip of
    the delivery system and the primary sheath such that the guidewire lumen is visible.