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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire."
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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