The Recall Desk

Manufacturer

Micro Therapeutics Inc, Dba Ev3 Neurovascular

14 recalls in our database name Micro Therapeutics Inc, Dba Ev3 Neurovascular as the manufacturing or recalling firm.

What the numbers show

Total
14
Critical
3
Severe
3
Most recent
2020-04-01

Of the 14 recalls from Micro Therapeutics Inc, Dba Ev3 Neurovascular we have scored against our rubric, 3 (21%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (21%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

  • SevereFDA (Devices)·Z-1527-2020·2020-04-01

    ev3 Pipeline Flex Embolization Device Recalled for Potential Fracture

    Micro Therapeutics Inc is recalling 1,050 ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving a part in the patient.

    Product
    ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2020·2020-04-01

    Ev3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk

    Micro Therapeutics is recalling 762 Ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving parts in the patient.

    Product
    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3022-2018·2018-09-19

    ev3 TurboHawk Peripheral Plaque Excision System Recall for Incompatible Accessories

    Micro Therapeutics is recalling 67 units of the ev3 TurboHawk Peripheral Plaque Excision System because packaged accessories are incompatible with the catheter, potentially preventing the removal of excised material.

    Product
    ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1701-2018·2018-05-23

    Ev3 MindFrame Capture Devices Recalled for Potential Wire Separation

    Micro Therapeutics is recalling MindFrame Capture LP Revascularization Devices because they may partially detach from the delivery wire.

    Product
    MindFrame 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
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0307-2017·2016-11-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0308-2017·2016-11-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0310-2017·2016-11-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2017·2016-11-16

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2016·2015-10-21

    Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Incorrect Instructions

    Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 23 Pipeline and Pipeline Flex Embolization Devices because they were shipped with EU-version Instructions for Use.

    Product
    -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
    Category
    Medical Device
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-1454-2014·2014-04-23

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1453-2014·2014-04-23

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2045-2013·2013-09-04

    Pipeline Embolization Device Recalled for Missing Contraindication Information

    Micro Therapeutics Inc is recalling 62 Pipeline Embolization Devices because the instructions for use are missing specific contraindications regarding pre-existing stents and medication designations.

    Product
    Pipeline 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 hypophys
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2472-2012·2012-10-03

    Ev3 Neurovascular Recalls Mislabeled Marathon Flow Directed Micro Catheters

    Ev3 Neurovascular is recalling 23 units of Marathon Flow Directed Micro Catheters because one lot may have been mislabeled.

    Product
    Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization mate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2471-2012·2012-10-03

    Ev3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters

    Ev3 Neurovascular is recalling 36 UltraFlow HPC Flow Directed Micro Catheters because one lot may have been mislabeled.

    Product
    UltraFlow 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 embolizat
    Category
    Medical Device
    Distribution
    Distributed nationwide