Ev3 MindFrame Capture Devices Recalled for Potential Wire Separation
Micro Therapeutics is recalling MindFrame Capture LP Revascularization Devices because they may partially detach from the delivery wire.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a mechanical defect (separation from the delivery wire) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 1,942 units of MindFrame Capture LP Revascularization Devices. These medical devices are intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset. The recall covers specific product numbers ranging from REF 300010 to REF 300018, with worldwide distribution.
The recall is being issued due to a potential issue where the devices may partially detach or separate from the delivery wire. This defect could compromise the device's function during the procedure.
Healthcare providers and patients should check their inventory or medical records for the affected product numbers and UDI codes listed in the recall notice. If the device is found, it should be removed from use and returned to the manufacturer according to their instructions.
The recalled product
- 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 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 1,942
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
- 00847536020160 (g) REF 300016: 00847536020139
- 00847536020177 (h) REF 300017: 00847536020146
- 00847536020184 (i) REF 300018: 00847536020153
- 00847536020191
Distribution
Distribution scope not specified by the agency.
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