Recall Z-1701-2018— Micro Therapeutics Inc, Dba Ev3 Neurovascular

Name: FDA recall Z-1701-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-26

Class I · Terminated

Class I FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2018-02-26, terminated 2021-09-30. It names one FDA 510(k) clearance: K141516. 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.. Reason: There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire..

Recalling firm: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Classification: Class I
Status: Terminated
Initiated: 2018-02-26
Terminated: 2021-09-30
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K141516 — MINDFRAME CAPTURE LP REVASCULARIZATION DEVICEMicro Therapeutics, Inc. d/b/a ev3 Neurovascular·cleared 2015-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.