CLASS I Device recall · Reported 23 May 2018 · FDA Enforcement Report

MindFrame Capture LP Revascularization Devices: Product Numbers: (a) recalled

Micro Therapeutics Inc is recalling MindFrame Capture LP Revascularization Devices: Product Numbers: (a). The recall was initiated on 26 Feb 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll 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

Quantity recalled1,942 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1701-2018
FDA event ID: 79463
Recalling firm: Micro Therapeutics Inc, Irvine, CA
Classification: Class I
Status: Terminated
Recall initiated: 26 Feb 2018
FDA classified: 16 May 2018
Reported: 23 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

26 Feb 2018	Recall initiated by company
16 May 2018	Classified by FDA	+79 days
23 May 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution

Questions about this recall

Why was it recalled?

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

Which lots 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

Where was it sold?

Worldwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Micro Therapeutics Inc

All 16

Reported	Class	Recall	Company	Reason	Where
15 Sep 2021Device	CLASS I	Pipeline Flex Embolization Device recalled by Micro Therapeutics Inc	Micro Therapeutics Inc	Other	49 states
15 Sep 2021Device	CLASS I	EV3 Pipeline Flex Embolization Device with Flex Shield Technology recalled	Micro Therapeutics Inc	Other	49 states
1 Apr 2020Device	CLASS I	ev3 Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics Inc	Other	Nationwide
1 Apr 2020Device	CLASS I	ev3 Pipeline Flex Embolization Device recalled by Micro Therapeutics Inc	Micro Therapeutics Inc	Other	Nationwide
19 Sep 2018Device	CLASS II	ev3 TurboHawk Perpheral Plaque Excision System For Surgical recalled	Micro Therapeutics Inc	Packaging Defects	10 states

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide