Recall Register

Micro Therapeutics Inc, Dba Ev3 Neurovascular: FDA recalls

FDA enforcement reports name Micro Therapeutics Inc, Dba Ev3 Neurovascular as the recalling firm in 8 events. The events have 14 product records. The recalls started from 2011 to 2020. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Micro Therapeutics Inc, Dba Ev3 Neurovascular
InitiatedProduct (first record)TypeClassRecordsStatus
14 Feb 2020ev3 Pipeline Flex Embolization Device. For neurological endovascular use.DeviceClass I2Terminated
10 Aug 2018ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.DeviceClass II1Terminated
26 Feb 2018MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke…DeviceClass I1Terminated
5 Oct 2016Pipeline 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…DeviceClass I4Terminated
4 Sep 2015-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from…DeviceClass II1Terminated
1 Apr 2014Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.DeviceClass I2Terminated
19 Jul 2013Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.DeviceClass II1Terminated
23 Sep 2011UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials…DeviceClass II2Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Micro Therapeutics Inc, Dba Ev3 Neurovascular: events for each product type
TypeEvents
Device8
Micro Therapeutics Inc, Dba Ev3 Neurovascular: events in each class
ClassEvents
Class I4
Class II4
Share of the events of the firm in Class I
50%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Micro Therapeutics Inc, Dba Ev3 Neurovascular, by the year that the recall started. The largest year is 2018, with 2 events.

Official channels

Cite this page

Recall Register. Micro Therapeutics Inc, Dba Ev3 Neurovascular: FDA recalls. https://recallregister.com/firm/micro-therapeutics-inc-dba-ev3-neurovascular/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Micro Therapeutics Inc, Dba Ev3 Neurovascular have?
Class I: 4 events. Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Micro Therapeutics Inc, Dba Ev3 Neurovascular?
FDA event 85069, which the firm started on 14 Feb 2020. The first product in the record is: ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
How many FDA recalls of Micro Therapeutics Inc, Dba Ev3 Neurovascular have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.