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 is
Check against the official notice below — it lists the full affected range.
Micro Therapeutics Inc, doing business as EV3 Neurovascular, is recalling 1,942 units of MindFrame Capture LP Revascularization Devices due to a potential issue where the devices may partially detach or separate from the delivery wire. The affected devices have been distributed worldwide and include multiple product numbers (REF 300010, 300011, 300012, 300013, and others) with various lot numbers identified by their UDI codes.
The recall affects specific product numbers and lot codes as detailed in the distribution records. The source document does not specify a remedy or required consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
Reason for recall: There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire. Distribution: Worldwide Distribution Quantity: 1,942 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.