Reported Oct 26, 2022 · Ongoing

Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR,…

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 NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, MitraClip G4 Clip Delivery System XT CE/CDS0702-XT, MitraClip G4 Clip Delivery System XTW CE/CDS0702-XTW, MitraClip G4 Clip Delivery Sys NT ROW/CDS0705-NT, MitraClip G4 Clip Delivery Sys NTW ROW/CDS0705-NTW, MitraClip G4 Clip Delivery Sys XT ROW/CDS0705-XT, MitraClip G4 Clip Delivery Sys XTW ROW/CDS0705-XTW, TriClip XT Clip Delivery Sys CE/TCDS0202-XT, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip XT Clip Delivery Sys ROW/TCDS0205-XT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT, TriClip G4 NT Delivery System CE/TCDS0302-NT, TriClip G4 NTW Delivery System CE/TCDS0302-NTW, TriClip G4 XT Delivery System CE/TCDS0302-XT, TriClip G4 XTW Delivery System CE/TCDS0302-XTW, TriClip G4 NT Delivery System ROW/TCDS0305-NT, TriClip G4 NTW Delivery System ROW/TCDS0305-NTW, TriClip G4 XT Delivery System ROW/TCDS0305-XT, TriClip G4 XTW Delivery System ROW/TCDS0305-XTW, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT. For cardiac procedures

Lot codes and dates: Part/UDI-GTIN
CDS0601-NTR/08717648226342
CDS0602-NTR/08717648226359
CDS0602-XTR/08717648226373
CDS0702-NT/08717648230950
CDS0702-NTW/08717648230974
CDS0702-XT/08717648230998
CDS0702-XTW/08717648231018
CDS0705-NT/08717648288616
CDS0705-NTW/08717648288630
CDS0705-XT/08717648288623
CDS0705-XTW/08717648288647
TCDS0202-XT/08717648229978
TCDS0202-NT/08717648229985
TCDS0205-XT/08717648288708
TCDS0205-NT/08717648288692
TCDS0302-NT/08717648334238
TCDS0302-NTW/08717648334252
TCDS0302-XT/08717648334245
TCDS0302-XTW/08717648334269
TCDS0305-NT/08717648334313
TCDS0305-NTW/08717648334337
TCDS0305-XT/08717648334320
TCDS0305-XTW/08717648334344
TCDS0202-NT/08717648229985
TCDS0205-NT/08717648288692 All lots
Amount recalled: 20,045

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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By hazard

Medical device recalls

Other recalls from Abbott Vascular

12 in total.

Where it was distributed

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