Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 3…

Recall date

February 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1701-2018

FDA classification

Class I

Brand / firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Sold / distributed

Worldwide Distribution

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.