medical Class II Updated 2019-06-05

Abbott Vascular recalls Abbott MitraClip XTR Clip Delivery System, UDI: 087176482263

Recalled Product

Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

Hazard / Issue

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.

Issued by

FDA

Affected States: FL, UT, IN, OK, TX, CO, LA, AZ, MO, AL, GA, CA, AR, KS, IL, HI, IA, KY, MA, DC, NY, NV, NM, NJ, MT, MD, NC, CT, MI, MN, OH, ND, NH, OR, PA, WI, WA, VA, WV, TN, SC, RI, DE, ME, NE, SD, MS, ID, VT
Lot/Code Info: All Serial Numbers.
View official government recall

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