Z-1701-2018Class I

MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012...

Name: Z-1701-2018 MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012...
Creator: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Published: 2018-02-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-02-26 / Terminated / root cause: manufacturing process

FDA source

Micro Therapeutics Inc, Dba Ev3 Neurovascular began a recall of 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)... on 2018-02-26. FDA classified it as Class I and gives the reason as "There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1701-2018
Classification: Class I
Status: Terminated
Initiated: 2018-02-26
Posted: 2018-05-16
Terminated: 2021-09-30
Recalling firm: Medtronic, Inc.
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.
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm initiated their recall via an Urgent Medical Device Recall letter, dated February 26, 2018. The letter identified the affected device, described the issue, product scope, and the actions to be taken. The firm recommended users remove and quarantine all affected and unexpired product in their inventory and return the affected products to Medtronic. Customers may contact their Medtronic representative if alternative product is needed. The Customer Confirmation Form should be completed and faxed to Medtronic at 1-949-434-5020, to the attention of Neurovascular Quality.
Quantity in commerce: 1,942 units
Distribution: Worldwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1701-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1701-2018	Class I	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-16

Product code NRY

K141516Class IIMindframe Capture Lp Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular / cleared 2015-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)