The Recall Desk

FDA (Devices) recall action 74425

Stryker Neurovascular recalled 28 products on 2016-07-20

The FDA (Devices) publishes a recall like this one as 28 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 28 pages.

Products
28
Announced
2016-07-20
Critical
0
Units
—

Why these products were recalled

Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.

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

26–28 of 28

  • HighFDA (Devices)··2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced their stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-07-20

    Stryker Target Nano Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may have reduced their stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Distribution
    0 states