Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Abbott MitraClip XTR Clip Delivery System Recalled by Abbott Vascular Due to Reports of implantable mitral valve repair system clips...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Vascular directly.
Affected Products
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Quantity: N/A
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 49 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
About Abbott Vascular
Abbott Vascular has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report