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

Recalled May 23, 2018 · FDA recall Z-1701-2018 · Micro Therapeutics Inc,

Hazard

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

Units

1,942 units

Sold at

Worldwide Distribution

Description

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

Product

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.

Manufacturer(s)

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →