The Recall Desk

Manufacturer

Oscor, Inc.

39 recalls in our database name Oscor, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
39
Critical
0
Severe
4
Most recent
2026-07-22

Of the 39 recalls from Oscor, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (10%) 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 39

  • SevereFDA (Devices)·Z-2678-2026·2026-07-22

    Abiomed Impella Introducer Kit Recalled Due to Potential Leakage

    Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.

    Product
    Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2680-2026·2026-07-22

    Abiomed Impella Introducer Kit recalled for potential fluid leakage

    Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.

    Product
    Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2679-2026·2026-07-22

    Abiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk

    Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.

    Product
    Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0646-2022·2022-02-23

    Destino Twist and Guidestar Devices Recalled for Potential Threaded Component Separation

    Oscor Inc. is recalling 549 units of Destino Twist and Guidestar devices due to potential separation between the threaded hub and cap. Affected devices were distributed in Tennessee, Pennsylvania, and the Czech Republic.

    Product
    Destino Twist 14F (also branded as Guidestar 14F)
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1329-2021·2021-04-07

    Oscor SafeSheath ULTRALITE 10F Recalled for Potential Open Sterile Seal

    Oscor, Inc. is recalling 500 units of the AngioDynamics SafeSheath ULTRALITE 10F due to a potential open seal on the sterile product.

    Product
    AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2019·2018-11-14

    Oscor TB Series Bipolar Pacing Leads Recalled for Connector Sliding

    Oscor, Inc. is recalling TB Series Bipolar Pacing Leads because the connector cap housing may slide, potentially exposing the connection wire and causing loss of pacing.

    Product
    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2017·2017-07-19

    Oscor ATAR Reusable Extension Cables Recalled for Connector Separation Risk

    Oscor, Inc. is recalling ATAR Reusable Extension Cables because they may separate from the connector during use, posing a risk to patients.

    Product
    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-2733-2017·2017-07-19

    Oscor ATAR Disposable Extension Cables Recalled for Connector Separation Risk

    Oscor, Inc. is recalling ATAR Disposable Extension Cables because they may separate from the connector during use, posing a risk to patients.

    Product
    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, AT
    Category
    Medical Device
    Distribution
    39 states
  • SevereFDA (Devices)·Z-0810-2017·2016-12-28

    Oscor Breezeway Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 255 Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of injury.

    Product
    OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0818-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled Due to Liner Fragmentation

    Oscor, Inc. is recalling 55 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0816-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Liner Fragmentation

    Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner may come out during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0811-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Fragmentation

    Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0808-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 33 units of the Adelante Breezway 10F Straight sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0812-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

    Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because an inner liner fragment was found during insertion. The recall covers 1,729 units distributed worldwide.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0803-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 74 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The device is used to introduce catheters to heart chambers.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0794-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 991 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0802-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling eight Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of device failure.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0817-2017·2016-12-28

    Oscor Recalls Medtronic Arrive Braided Transseptal Sheaths Due to Liner Fragmentation

    Oscor, Inc. is recalling 991 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0805-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 110 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0814-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

    Oscor, Inc. is recalling 186 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner was found during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0807-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 34 units of the Adelante Breezeway 10F Straight sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0796-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 61 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The product was distributed in the US and internationally.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0809-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 20 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0799-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 21 units of the Adelante Breezway 8F Straight sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0801-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling specific lots of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states