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.

Read the official notice →
Date
2026-10-07
Country
United States
Brand
Micro Therapeutics
Product
Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device…
Classification
Class II
Units
U.S. Nationwide distribution in the states of GA and TX.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Micro Therapeutics recalls

  1. 2026-07-29
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    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

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  3. 2025-03-12
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    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,…

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    FDA · DeviceMicro Therapeutics, Inc.Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL,…Official notice →
  5. 2024-03-13
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    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 →
  7. 2022-08-24
  8. US
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    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 →
  9. 2022-06-22
  10. US
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    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 →
All 6 Micro Therapeutics recalls →

Other drugs & medical recalls in the United States

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