Abbott Vascular recalls MitraClip G4 CDS and TriClip devices due to potential clip locking malfunctions that could lead to severe heart valve issues during cardiac procedures.
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 G4 and TriClip devices because they may lock incorrectly during heart valve procedures. This could cause serious complications like device embolization or tissue injury if the clip procedure fails.
The devices may lock incorrectly during the procedure, which could lead to the clip failing to stay in place. This might cause the heart valve to leak severely or the device to become dislodged, potentially causing tissue damage or other serious complications.
Cardiac surgeons and medical professionals who use these devices for heart valve procedures. Patients undergoing these procedures are at risk if the device malfunctions during surgery.
Check for the model numbers CDS0704-NT, CDS0704-NTW, CDS0704-XT, CDS0704-XTW, TCDS0203-NT, TCDS0203-XT, TCDS0303-NT, TCDS0303-NTW, TCDS0303-XT, or TCDS0303-XTW on the device packaging or labels. These devices were used in cardiac procedures.
Look for the model numbers listed in the recall notice on the device packaging or labels.
Reach out to Abbott Vascular directly for guidance on next steps if you have the recalled device.
The recall includes MitraClip G4 CDS NT REPAIR-MR Clinical, MitraClip G4 CDS NTW REPAIR-MR Clinical, and TriClip NT/XT/XTW delivery systems used in cardiac procedures.
Check the device model number and contact Abbott Vascular for specific instructions on next steps.
Yes, if the clip locks incorrectly, it could lead to severe mitral regurgitation, device embolization, or tissue injury.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0117-2023 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-0117-2023 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.
