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Micro Therapeutics, Inc. FDA Recalls
11 recalls on file across devices, 4 of them Class I and 11 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm floClass IIJun 8, 2026Incorrect labeling - embolization devices labeled as 3.0 mm |
| Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm floClass IIJun 8, 2026Incorrect labeling - embolization devices labeled as 3.0 mm |
| Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-3Class IJan 30, 2025Use of embolization device with diameters greater-than-or-eq |
| Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-3Class IJan 30, 2025Use of embolization device with diameters greater-than-or-eq |
| The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infClass IIJan 11, 2024European version of microcatheter were distributed within US |
| The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infClass IIJan 11, 2024European version of microcatheter were distributed within US |
| Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx OnlyClass IIJun 30, 2022Outer carton packaging of microcatheters were exposed to wet |
| Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx OnlyClass IIJun 30, 2022Outer carton packaging of microcatheters were exposed to wet |
| AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;Class IIApr 27, 2022Due to incorrect size and configuration labeling of the deta |
| EV3 Pipeline Flex Embolization Device with Flex Shield TechnologyClass IJul 13, 2021Due to potential push wire fractures in the delivery system |
| Pipeline Flex Embolization DeviceClass IJul 13, 2021Due to potential push wire fractures in the delivery system |