Reported Oct 26, 2022 · Ongoing
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT,…
Abbott Vascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 3200 Lakeside Dr · Santa Clara, CA · 95054-2807
Is this the product you have?
- Product/PartMitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW. For cardiac procedures
- Lot codes and dates
- Part/UDI
CDS0601-XTR/08717648226366CDS0701-NT/08717648230943CDS0701-NTW/08717648230967CDS0701-XT/08717648230981CDS0701-XTW/08717648231001All lots
- Part/UDI
- Amount recalled
- 18,042
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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