ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Class I - DangerousWhat Should You Do?
- Check if you have this product: A213373 and A216702
- 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:
- ev3, Inc.
- Reason for Recall:
- Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Product Codes/Lot Numbers:
A213373 and A216702
Distribution:
Distributed in: US, CA, GA, LA, MI, MS, MO, NV, NH, NY, OH, PA, SD, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1552-2016
Related Recalls
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.