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PipelineTM Flex Embolization Device with Shield TechnologyTM

Micro Therapeutics, Inc. · Model PED2-450-30 · UDI-DI 00763000284565

OUT Prescription
0
510(k) clearances
11,926
Adverse events (616 deaths)
13
Recalls
13
Facilities

Description

STENT PED2-450-30 V06 E-IFU

Recalls

DateFirmReason
2026-06-08Micro 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 mm implants.
2026-06-08Micro 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 mm implants.
2025-09-05MICROVENTION 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 open or not properly ap
2025-01-30Micro 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 narrowing/braid collapse
2025-01-30Micro 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 narrowing/braid collapse
2023-06-07MICROVENTION INC.Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
2021-07-13Micro 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.
2021-07-13Micro 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.
2020-02-14Micro Therapeutics Inc, Dba Ev3 NeurovascularEmbolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of
2020-02-14Micro Therapeutics Inc, Dba Ev3 NeurovascularEmbolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.