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Intracranial Aneurysm Flow Diverter
FDA product code OUT · Class 3 · Unknown
965
Registered devices
11,926
Adverse events
13
Recalls
0
510(k) clearances
Devices with this code
PIPELINE — Micro Therapeutics, Inc.Pipeline — Micro Therapeutics, Inc.Surpass Elite — Stryker CorporationPipelineTM Flex Embolization Device with Shield TechnologyTM — Micro Therapeutics, Inc.PipelineTM Vantage Embolization Device with Shield TechnologyTM — Micro Therapeutics, Inc.Surpass Evolve — Stryker CorporationPIPELINE — Micro Therapeutics, Inc.PIPELINE — Micro Therapeutics, Inc.PIPELINE — Micro Therapeutics, Inc.PipelineTM Flex Embolization Device with Shield TechnologyTM — Micro Therapeutics, Inc.PIPELINE — Micro Therapeutics, Inc.PIPELINE — Micro Therapeutics, Inc.Pipeline TM Flex Embolization Device with Shield Technology TM — Micro Therapeutics, Inc.PIPELINE — Micro Therapeutics, Inc.PipelineTM Flex Embolization Device with Shield TechnologyTM — Micro Therapeutics, Inc.Stent — Microvention, Inc.Surpass Elite — Stryker CorporationSurpass Elite — Stryker CorporationPIPELINE — Micro Therapeutics, Inc.Pipeline — Micro Therapeutics, Inc.PIPELINE — Micro Therapeutics, Inc.Pipeline — Micro Therapeutics, Inc.Pipeline TM Flex Embolization Device with Shield Technology TM — Micro Therapeutics, Inc.PIPELINE — Micro Therapeutics, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | Micro Therapeutics, Inc. | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 m |
| 2026-06-08 | Micro Therapeutics, Inc. | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 m |
| 2025-09-05 | MICROVENTION INC. | Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely ope |
| 2025-01-30 | Micro Therapeutics, Inc. | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narr |
| 2025-01-30 | Micro Therapeutics, Inc. | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narr |
| 2023-06-07 | MICROVENTION INC. | Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended. |
| 2021-07-13 | Micro Therapeutics Inc, | Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. |
| 2021-07-13 | Micro Therapeutics Inc, | Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. |
| 2020-02-14 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where th |
| 2020-02-14 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where th |
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