The Recall Desk

Manufacturer

Nitinol Devices and Components, Inc.

12 recalls in our database name Nitinol Devices and Components, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
4
Most recent
2014-07-02

Of the 12 recalls from Nitinol Devices and Components, 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 (33%) 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.

1–12 of 12

  • SevereFDA (Devices)·Z-1822-2014·2014-07-02

    Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and inter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1812-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1815-2014·2014-07-02

    Nitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2014·2014-07-02

    Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket can be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica The HydroFinity Hydrophi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires due to reports of the outer polymer jacket being damaged during use.

    Product
    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA; Manufactured in Costa Rica The HydroFinity Hydr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1819-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity Hydrophi
    Category
    Medical Device
    Distribution
    Distributed nationwide