Reported May 23, 2018 · Terminated
MindFrame Capture LP Revascularization Devices
Micro Therapeutics Inc., dba Ev3 Neurovascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micro Therapeutics Inc, Dba Ev3 Neurovascular · 9775 Toledo Way · Irvine, CA · 92618-1811
Is this the product you have?
MindFrame Capture LP Revascularization Devices
9 of 9 products
| Model / number | Product as published |
|---|---|
300010 | (b) |
300011 | (c) |
300012 | (d) |
300013 | (e) |
300014 | (f) |
300015 | (g) |
300016 | (h) |
300017 | (i) |
300018 | Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset. |
- Amount recalled
- 1,942 units
Why it was recalled
Stop using this product now
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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