Drugs & medicalClass II

Contego Medical LLC recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF:…

Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The…

Read the official notice →
Date
2025-10-22
Country
United States
Brand
Contego Medical
Product
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF:…
Classification
Class II
Units
US Nationwide distribution in the states of FL, CO, CA, IL, NC, KY, TX, PA,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Contego Medical recalls

  1. 2026-08-12
  2. US
    Drugs & medicalClass II

    Contego Medical, Inc recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF:…

    Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this…

    FDA · DeviceContego Medical, IncUS Nationwide distribution in the states of IL, FL, NC, WI, KY, AL, VA, DE,…Official notice →
All 2 Contego Medical recalls →

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    FDA · DeviceBoston Scientific CorporationWorldwideOfficial notice →
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