The Recall Desk

FDA (Devices) recall action 75358

Micro Therapeutics Inc, Dba Ev3 Neurovascular recalled 4 products on 2016-11-16

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-11-16
Critical
2
Units
92,142

Why these products were recalled

Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

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

1–4 of 4

  • SevereFDA (Devices)··2016-11-16

    Ev3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires

    Micro Therapeutics Inc is recalling X-Celerator Hydrophilic Exchange Guidewires because PTFE coating delamination may release material into the bloodstream.

    Product
    X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-06
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-11-16

    Ev3 Neurovascular Recalls Marathon and UltraFlow Micro Catheters

    Micro Therapeutics Inc. is recalling Marathon and UltraFlow HPC Flow Directed Micro Catheters because PTFE coating may delaminate and enter the bloodstream.

    Product
    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2016-11-16

    FDA Recalls Pipeline Embolization Devices Due to Coating Delamination

    Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.

    Product
    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal sege
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2016-11-16

    Ev3 Neurovascular Alligator Retrieval Device Recalled for Coating Defect

    Micro Therapeutics Inc. is recalling 3,337 Alligator Retrieval Devices because the PTFE coating may delaminate and detach, potentially entering the bloodstream.

    Product
    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
    Category
    Distribution
    1 state