Z-1701-2018 Class I Terminated
FDA device recall Z-1701-2018 was initiated by Micro Therapeutics Inc, Dba Ev3 Neurovascular on February 26, 2018 and is designated Class I. Reason for recall: There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire. The recall status is terminated (terminated September 30, 2021). Affected quantity: 1,942 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- February 26, 2018
- Termination Date
- September 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,942 units
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.
Reason for Recall
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
Distribution Pattern
Worldwide Distribution
Code Information
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