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.

26–39 of 39

  • HighFDA (Devices)·Z-0819-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragment

    Oscor, Inc. is recalling 45 units of 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 GLOBALCatalog # 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-0792-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 30 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 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-0798-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.

    Product
    OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 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-0804-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 124 units of the Adelante Breezeway 10F sheath because a fragment of the inner liner detached during insertion. The product was distributed worldwide.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 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-0797-2017·2016-12-28

    Oscor Medical Device Recall for Sheath Liner Fragmentation

    Oscor, Inc. is recalling 11 Adelante Breezeway sheaths because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 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-0795-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 76 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 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-0791-2017·2016-12-28

    Oscor Medical Sheath Recalled for Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 87 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 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-0806-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 16 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C120¿ 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-0793-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 21 units of the Adelante Breezeway 8F sheath because a fragment of the inner liner detached during insertion. The product is distributed worldwide.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 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-0790-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 156 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 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-0813-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

    Oscor, Inc. is recalling 215 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-0800-2017·2016-12-28

    Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation

    Oscor, Inc. is recalling 22 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.

    Product
    OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 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-0815-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Fragment Release

    Oscor, Inc. is recalling 59 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 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-0165-2013·2012-11-07

    Oscor Recalls Myocardial Heart Wires Due to Spacing Defect

    Oscor, Inc. is recalling specific models of myocardial heart wires because the spacing between the anchoring zig-zag and the electrode is out of specification.

    Product
    Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
    Category
    Medical Device
    Distribution
    11 states