Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery System CLIN/TCDS0303-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT. For cardiac procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part/UDI-GTIN: CDS0704-NT/08717648234576, CDS0704-NTW/08717648234590, CDS0704-XT/08717648234583, CDS0704-XTW/08717648234606, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961, TCDS0303-NT/08717648334276, TCDS0303-NTW/08717648334290, TCDS0303-XT/08717648334283, TCDS0303-XTW/08717648334306, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961 All lots.
- 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:
- Abbott Vascular
- Reason for Recall:
- An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery System CLIN/TCDS0303-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT. For cardiac procedures.
Product Codes/Lot Numbers:
Part/UDI-GTIN: CDS0704-NT/08717648234576, CDS0704-NTW/08717648234590, CDS0704-XT/08717648234583, CDS0704-XTW/08717648234606, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961, TCDS0303-NT/08717648334276, TCDS0303-NTW/08717648334290, TCDS0303-XT/08717648334283, TCDS0303-XTW/08717648334306, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961 All lots.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0117-2023
Related Recalls
20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Abbott Vascular
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.