Home / Recalls / Micro Therapeutics Inc, Dba Ev3 Neurovascular / Z-1701-2018

Z-1701-2018 Class I Terminated

Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular — Irvine, CA

Recall Details

Product Type
Devices
Report Date
May 23, 2018
Initiation Date
February 26, 2018
Termination Date
September 30, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,942 units

Product Description

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 intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.

Reason for Recall

There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.

Distribution Pattern

Worldwide Distribution

Code Information

All lot numbers: Product Number: UDI (a) REF 300010: 00843889031334, 00843889031341, 00847536020207 (b) REF 300011: 00843889031365, 00843889031372, 00847536020214 (c) REF 300012: 00843889031396, 00843889031402, 00847536020221 (d) REF 300013: 00843889031426, 00843889031433, 00847536020238 (e) REF 300014: NOT DISTRIBUTED (f) REF 300015: 00847536020122, 00847536020160 (g) REF 300016: 00847536020139, 00847536020177 (h) REF 300017: 00847536020146, 00847536020184 (i) REF 300018: 00847536020153, 00847536020191

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  • Z-3022-2018 Class II — ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XT (August 10, 2018)
  • Z-0307-2017 Class I — Pipeline Embolization Device (Pipeline Classic) The device is indicated for the (October 5, 2016)
  • Z-0310-2017 Class I — X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-060 (October 5, 2016)
  • Z-0309-2017 Class I — Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cathete (October 5, 2016)
  • Z-0308-2017 Class I — Alligator Retrieval Device The device is intended for use in the peripheral and (October 5, 2016)
  • Z-0120-2016 Class II — -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipelin (September 4, 2015)
  • Z-1453-2014 Class I — Pipeline Embolization Device (PED). Used endovascular treatment of adults with (April 1, 2014)
  • Z-1454-2014 Class I — Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature f (April 1, 2014)