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Micro Therapeutics Inc, Recalls
14 recalls on record · October 3, 2012 to April 1, 2020 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
April 1, 2020Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Hazard: Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
April 1, 2020Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Hazard: Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
September 19, 2018Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C f
Hazard: The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.
May 23, 2018Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d)
Hazard: There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
November 16, 2016Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V
Hazard: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
November 16, 2016Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended
Hazard: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
November 16, 2016Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body remov
Hazard: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
November 16, 2016Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 ye
Hazard: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
October 21, 2015Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices
Hazard: The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
April 23, 2014Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Hazard: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
April 23, 2014Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal c
Hazard: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
September 4, 2013Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of ad
Hazard: Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "
October 3, 2012Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is i
Hazard: The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
October 3, 2012Medical DevicesFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro C
Hazard: The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.