Recall Atlas

Micro Therapeutics recalls

6 official recalls and safety alerts involving Micro Therapeutics since 2022-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Micro Therapeutics or the relevant agency.

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization…

    Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.

    FDA · DeviceMicro Therapeutics, Inc.U.S. Nationwide distribution in the states of GA and TX.Official notice →
  3. 2026-07-29
  4. US
    Drugs & medicalClass II

    Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter

    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.

    FDA · DeviceMicro Therapeutics, Inc.US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY,…Official notice →
  5. 2025-03-12
  6. US
    Drugs & medicalClass I

    Micro Therapeutics, Inc. recalls Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20,…

    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…

    FDA · DeviceMicro Therapeutics, Inc.Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL,…Official notice →
  7. 2024-03-13
  8. US
    Drugs & medicalClass II

    Micro Therapeutics, Inc. recalls The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the…

    European version of microcatheter were distributed within US which contain a different "Indications for Use".

    FDA · DeviceMicro Therapeutics, Inc.US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, HI, IA,…Official notice →
  9. 2022-08-24
  10. US
    Drugs & medicalClass II

    Micro Therapeutics, Inc. recalls Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only

    Outer carton packaging of microcatheters were exposed to wet substance during transport.

    FDA · DeviceMicro Therapeutics, Inc.US Nationwide Distribution: None OUS: BrazilOfficial notice →
  11. 2022-06-22
  12. US
    Drugs & medicalClass II

    Micro Therapeutics, Inc. recalls AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;

    Due to incorrect size and configuration labeling of the detachable coil system.

    FDA · DeviceMicro Therapeutics, Inc.International distribution in the countries of China and Republic of Korea.Official notice →