Abbott Vascular: 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.

Agency Publication Date: October 20, 2022

Affected Products

Product: Product/Part: MitraClip 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.

Part/UDI: CDS0601-XTR/08717648226366, CDS0701-NT/08717648230943, CDS0701-NTW/08717648230967, CDS0701-XT/08717648230981, CDS0701-XTW/08717648231001, All lots.

Product: Product/Part: MitraClip 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

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.

Product: 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 Syste

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.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90840

Status: Active

Manufacturer: Abbott Vascular

Manufactured In: United States

Units Affected: 3 products (18,042; 20,045; 767)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Part/UDI: CDS0601-XTR/08717648226366, CDS0701-NT/08717648230943, CDS0701-NTW/08717648230967, CDS0701-XT/08717648230981, CDS0701-XTW/08717648231001, All lots.