The Recall Desk

FDA (Devices) recall action 69669

Stryker Neurovascular recalled 5 products on 2014-12-10

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2014-12-10
Critical
0
Units
5

Why these products were recalled

Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2014-12-10

    Stryker GDC 360 Coils Recalled for Expiration Date Violations

    Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped beyond their expiration dates.

    Product
    GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a)…
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2014-12-10

    Stryker Neurovascular Recalls Expired Target Detachable Coils

    Stryker Neurovascular is recalling Target Detachable Coils shipped to US customers beyond their expiration date.

    Product
    Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are indicated for endovascular embolization of: "…
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2014-12-10

    Stryker GDC 360 Coils Recalled for Expiration Date Violations

    Stryker Neurovascular is recalling GDC 360 coils and related devices shipped to US customers beyond their expiration dates.

    Product
    GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be…
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2014-12-10

    Stryker Neurovascular Recalls Expired Gateway PTA Balloon Catheters

    Stryker Neurovascular is recalling Gateway PTA Balloon Catheters shipped to US customers beyond their expiration date.

    Product
    Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion.
    Category
    Distribution
    4 states
  • ModerateFDA (Devices)··2014-12-10

    Stryker GDC 360 Coils Recalled for Expiration Date Violations

    Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped to US customers beyond their expiration dates.

    Product
    GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a)…
    Category
    Distribution
    4 states