The Recall Desk

Manufacturer

Ev3, Inc.

11 recalls in our database name Ev3, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
1
Severe
3
Most recent
2025-01-22

Of the 11 recalls from Ev3, Inc. we have scored against our rubric, 1 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (27%) 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.

1–11 of 11

  • HighFDA (Devices)·Z-0904-2025·2025-01-22

    Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation

    Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.

    Product
    Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0694-2022·2022-03-16

    Medtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect

    ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.

    Product
    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0695-2022·2022-03-16

    Medtronic TurboHawk Plus atherectomy system recalled for potential tip detachment

    The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.

    Product
    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0450-2022·2022-01-26

    Medtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk

    Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.

    Product
    Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0451-2022·2022-01-26

    Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage

    Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.

    Product
    Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2048-2016·2016-06-29

    Medtronic Recalls Two EverFiex Stents Due to Outer Box Mislabeling

    Medtronic is recalling two Protege EverFiex Self-expanding Peripheral Stent Systems from lot A164580 because the outer box size label may not match the device inside.

    Product
    EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0878-2015·2015-01-07

    Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error

    Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected units were distributed internationally.

    Product
    ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0879-2015·2015-01-07

    Ev3 Recalls Protege Rx Tapered Carotid Stent Systems Due to Labeling Error

    Ev3, Inc. is recalling two lots of Protege Rx Tapered Carotid Stent Systems due to a product labeling error. The affected devices were distributed internationally.

    Product
    ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1489-2014·2014-04-30

    Ev3 Recalls EverCross PTA Dilatation Catheters Due to Labeling Error

    Ev3 is recalling two lots of EverCross PTA Dilatation Catheters because of a discrepancy in the balloon and delivery catheter lengths printed on the product labeling.

    Product
    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
    Category
    Medical Device
    Distribution
    6 states