Micro Therapeutics Inc, Dba Ev3 Neurovascular: Medical Device Recall in 2018 - (Recall #: Z-1701-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: February 26, 2018

Date Posted: May 23, 2018

Recall Number: Z-1701-2018

Event ID: 79463

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,942 units

Code Information:

All lot numbers: Product Number: UDI (a) REF 300010: 00843889031334, 00843889031341, 00847536020207 (b) REF 300011: 00843889031365, 00843889031372, 00847536020214 (c) REF 300012: 00843889031396, 00843889031402, 00847536020221 (d) REF 300013: 00843889031426, 00843889031433, 00847536020238 (e) REF 300014: NOT DISTRIBUTED (f) REF 300015: 00847536020122, 00847536020160 (g) REF 300016: 00847536020139, 00847536020177 (h) REF 300017: 00847536020146, 00847536020184 (i) REF 300018: 00847536020153, 00847536020191

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated