Recall Z-1687-2019 ยท NKM Mitral Valve Repair Devices
Abbott Vascular
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
| Date | May 1, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Use error |
| Action | On 05/01/19, Urgent Medical Device Correction notices were sent to implanting physicians, via personal delivery or email, informing them that under normal use conditions, this failure will not occur. To prevent unintended force from being applied to the clip, revised instructions, including definition and related technique, for performing the steps "Establish Final Angle" and "Invert the Clip Arms" were developed and provided herein. The revised instructions will be applied to the shared XTR and NTR Clip Delivery System Instructions for Use. Unintended excessive force applied to the NTR Clip D |
| Distribution | U.S.: 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. Foreign (OUS): AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, Canada, CROATIA, CZECH REPUBLIC, DENMARK, F |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.