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Micro Therapeutics Recalls
11 recalls on record · September 15, 2021 to July 29, 2026 · Medical Devices
Recalls by year
21
22
24
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26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
July 29, 2026Medical DevicesFDA
Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flo
Hazard: 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.
July 29, 2026Medical DevicesFDA
Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flo
Hazard: 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.
March 12, 2025Medical DevicesFDA
Micro Therapeutics, Inc. recalls Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-3
Hazard: 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) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
March 12, 2025Medical DevicesFDA
Micro Therapeutics, Inc. recalls Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-3
Hazard: 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) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
March 13, 2024Medical DevicesFDA
Micro Therapeutics, Inc. recalls The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf
Hazard: European version of microcatheter were distributed within US which contain a different "Indications for Use".
March 13, 2024Medical DevicesFDA
Micro Therapeutics, Inc. recalls The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf
Hazard: European version of microcatheter were distributed within US which contain a different "Indications for Use".
August 24, 2022Medical DevicesFDA
Micro Therapeutics, Inc. recalls Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
Hazard: Outer carton packaging of microcatheters were exposed to wet substance during transport.
August 24, 2022Medical DevicesFDA
Micro Therapeutics, Inc. recalls Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Hazard: Outer carton packaging of microcatheters were exposed to wet substance during transport.
June 22, 2022Medical DevicesFDA
Micro Therapeutics, Inc. recalls AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Hazard: Due to incorrect size and configuration labeling of the detachable coil system.
September 15, 2021Medical DevicesFDA
Micro Therapeutics Inc, recalls EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Hazard: 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.
September 15, 2021Medical DevicesFDA
Micro Therapeutics Inc, recalls Pipeline Flex Embolization Device
Hazard: 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.