FDAClass IMay 23, 2018

MindFrame Capture LP Revascularization Devices: Product recall

MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF…

Why was MindFrame Capture LP Revascularization Devices: Product recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Quantity
1,942 units
Distribution
Worldwide Distribution
Recall date
May 23, 2018
Classification
Class I
Status
Terminated
Agency
FDA (device)
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