FDA-Device2018-05-23Class I
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.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Hazard
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
Sold states
Worldwide Distribution
Affected count
1,942 units
Manufactured in
9775 Toledo Way, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1701-2018Don't want to check this manually?
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