Abbott recalls MitraClip XTR Clip Delivery System due to risk of clips opening unexpectedly during implantation, potentially requiring additional surgery. Affected units have specific serial numbers.
Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.
Abbott is recalling its MitraClip XTR Clip Delivery System because clips can unexpectedly open during surgery, leading to additional procedures. This affects patients who received the device for heart valve repair.
The delivery system's clips can open unexpectedly during implantation due to excessive force. This may cause the clips to become nonfunctional, requiring additional surgery to fix the issue.
Patients who received the MitraClip XTR Clip Delivery System for heart valve repair are most at risk. The recall applies to all units with the specific serial numbers listed in the notice.
Check the product's unique device identifier (UDI) number 08717648226366 or part number CDS0601-XTR. The device is sold only with a prescription and is sterile.
Look for the UDI number 08717648226366 or part number CDS0601-XTR on the device packaging.
The clips can unexpectedly open during implantation due to excessive force, potentially requiring additional surgery.
Check the product details for the UDI number 08717648226366 or part number CDS0601-XTR. Contact Abbott Vascular for further instructions.
The recall states that the clips may become nonfunctional, leading to additional surgery, but no specific injury details are provided.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1687-2019 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1687-2019 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.
