CaptureTM recallZ-1701-2018 · Micro Therapeutics Inc, Dba Ev3 Neurovascular · initiated Feb 26, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Micro Therapeutics Inc, Dba Ev3 Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-1701-2018
- Status
- Terminated
- Initiated by the company
- Feb 26, 2018
- Posted by the FDA
- May 16, 2018
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Quantity
- 1,942 units
- Product code
- NRY
- FDA submissions
- K141516
- Distribution
- Worldwide Distribution
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- CaptureTM 300015Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
- CaptureTM 300016Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
- CaptureTM 300017Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
- CaptureTM 300018Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
- CaptureTM 300015Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
- CaptureTM 300016Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
- CaptureTM 300017Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
- CaptureTM 300018Micro Therapeutics, Inc. · CATHETER, THROMBUS RETRIEVER1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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