FDA-Device2022-10-26Class II
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery Syste
Abbott Vascular
Hazard
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.
Sold states
Worldwide distribution - US Nationwide including in the states of PR, WA, NE, MO, IA, KS, TN, MN, ND, MD, VA, MA, PA, DC, LA, KY, CA, NV, IL, WI, TX, CT, VT, AL, AR, GA, MS, MI, OH, FL, NC, NJ, CO, NY, DE, OR, SC, IN, HI, AZ, NH, ME, WV, OK, ID, UT, MT, NM, RI, AK, SD and the countries of AE, AR, AT, AU, BE, BG, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LU, MT, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RE, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW.
Affected count
767
Manufactured in
3200 Lakeside Dr, N/A, Santa Clara, CA, United States
Products
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery System CLIN/TCDS0303-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT. For cardiac procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2023Don't want to check this manually?
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