The Recall Desk

Manufacturer

Micro Therapeutics Inc,

11 recalls in our database name Micro Therapeutics Inc, as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
1
Severe
3
Most recent
2026-07-29

Of the 11 recalls from Micro Therapeutics Inc, we have scored against our rubric, 1 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (27%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • ModerateFDA (Devices)·Z-2774-2026·2026-07-29

    Embolization devices recalled due to incorrect labeling of implant dimensions

    Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.

    Product
    Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2773-2026·2026-07-29

    Pipeline Flex Embolization Devices Recalled Due to Incorrect Labeling of Implant Length

    Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labeled implant length does not match the actual device length.

    Product
    Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1245-2025·2025-03-12

    Medtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk

    Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.

    Product
    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1246-2025·2025-03-12

    Medtronic Pipeline Vantage device recall: deformation may cause blood clots

    The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.

    Product
    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1252-2024·2024-03-13

    FDA Recalls Apollo Onyx Delivery Microcatheter Due to Labeling Mismatch

    FDA is recalling Apollo Onyx Delivery Microcatheters distributed in the US with incorrect European labeling. The devices contain different indications for use than those approved for the US market.

    Product
    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2024·2024-03-13

    Apollo Onyx Delivery Microcatheter recalled for incorrect indications for use

    Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.

    Product
    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2022·2022-08-24

    Echelon-14 Micro Catheter Recall Due to Moisture Exposure During Transport

    Micro Therapeutics is recalling Echelon-14 Micro Catheters because outer packaging was exposed to moisture during transport. The moisture exposure could compromise the sterility or function of the device.

    Product
    Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1556-2022·2022-08-24

    FDA Recalls Echelon-14 Microcatheters Due to Moisture-Exposed Packaging

    Micro Therapeutics is recalling Echelon-14 microcatheters whose outer carton packaging was exposed to a wet substance during transport, posing a risk to device sterility.

    Product
    Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2022·2022-06-22

    FDA Recalls Axium Detachable Coil Systems for Incorrect Labeling

    Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.

    Product
    AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2402-2021·2021-09-15

    Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk

    Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.

    Product
    Pipeline Flex Embolization Device
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2403-2021·2021-09-15

    EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk

    Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.

    Product
    EV3 Pipeline Flex Embolization Device with Flex Shield Technology
    Category
    Medical Device
    Distribution
    49 states