FDA recall Z-1701-2018

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 for recall

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

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2018-02-26

Report date

2018-05-23

Termination date

2021-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1701-2018