Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # B177543 UDI: (00) 847536006270
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Micro Therapeutics, Inc.
- Reason for Recall:
- Outer carton packaging of microcatheters were exposed to wet substance during transport.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Product Codes/Lot Numbers:
Lot # B177543 UDI: (00) 847536006270
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1556-2022
Related Recalls
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
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
European version of microcatheter were distributed within US which contain a different "Indications for Use".