Food, drugs, devices › Micro Therapeutics Inc, Dba Ev3 Neurovascular
Device recall: Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 yea
FDA enforcement event 75358 is a device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular of Irvine, CA, initiated 5 Oct 2016 and classified Class I, with 4 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 3% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 11 Oct 2017. Initiation: voluntary: firm initiated. Micro Therapeutics Inc, Dba Ev3 Neurovascular has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA.
Reason for recall
"Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream."
Distribution
"Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0307-2017 | 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 segements. Catalog No. FA-71300-25V09… | 11,860 units | Class I | Terminated | 16 Nov 2016 |
| Z-0308-2017 | 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 | 3,337 units | Class I | Terminated | 16 Nov 2016 |
| Z-0309-2017 | 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 diagnostic materials such as contrast… | 66,429 units | Class I | Terminated | 16 Nov 2016 |
| Z-0310-2017 | 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 103-0601-300V10 103-0602-300V09 103-0601-300V11… | 10,516 units | Class I | Terminated | 16 Nov 2016 |
Context
Other enforcement events for Micro Therapeutics Inc, Dba Ev3 Neurovascular
All 8 events for Micro Therapeutics Inc, Dba Ev3 Neurovascular
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Oct 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.