Abbott Vascular recalls MitraClip NTR and other clip delivery systems due to increased risk of clip locking malfunctions during cardiac procedures, which may cause severe mitral regurgitation or device embolization.
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.
Abbott Vascular is recalling several MitraClip and TriClip clip delivery systems because they can malfunction during cardiac procedures, potentially causing severe mitral regurgitation, device embolization, or tissue injury. This risk is due to issues with the clip locking mechanism under certain use conditions.
The clip locking mechanism in these devices can malfunction during cardiac procedures, leading to unsuccessful clip placement. This may cause severe mitral regurgitation, device embolization, or tissue injury if the clip does not lock properly.
Patients undergoing cardiac procedures who use the recalled MitraClip or TriClip clip delivery systems are most at risk. The specific models and lots are listed in the recall notice.
Check the product label for model numbers like CDS0601-NTR, CDS0602-NTR, or TCDS0202-NT. The recall includes MitraClip and TriClip clip delivery systems used in cardiac procedures.
Look for model numbers such as CDS0601-NTR, CDS0602-NTR, or TCDS0202-NT on the device label.
The recall includes MitraClip NTR (CDS0601-NTR/CDS0602-NTR), MitraClip G4 (CDS0702-NT/CDS0702-NTW/CDS0702-XT/CDS0702-XTW), and TriClip G4 (TCDS0302-NT/TCDS0302-NTW/TCDS0302-XT/TCDS0302-XTW) clip delivery systems.
The recall is due to increased risk of clip locking malfunctions during cardiac procedures, which can lead to severe mitral regurgitation, device embolization, or tissue injury.
Check the product label for model numbers listed in the recall. If you have the affected models, contact Abbott Vascular for further instructions.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0116-2023 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-0116-2023 from Abbott Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
