The Recall Desk

FDA (Devices) recall action 67893

Micro Therapeutics Inc, Dba Ev3 Neurovascular recalled 2 products on 2014-04-23

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-04-23
Critical
1
Units
—

Why these products were recalled

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2014-04-23

    Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect

    Ev3 Neurovascular is recalling 32 Pipeline Embolization Devices because the PTFE coating may delaminate and detach from the delivery wire.

    Product
    Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2014-04-23

    FDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk

    Micro Therapeutics Inc is recalling Alligator Retrieval Devices because the PTFE coating may delaminate and detach from the delivery wire.

    Product
    Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
    Category
    Distribution
    1 state