{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196099", "product_res_number": "Z-0116-2023", "event_date_initiated": "2022-09-08", "event_date_posted": "2022-10-20", "recall_status": "Open, Classified", "res_event_number": "90840", "product_code": "NKM", "product_description": "Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR,\nMitraClip NTR Clip Delivery System CE/CDS0602-NTR,\nMitraClip XTR Clip Delivery System CE/CDS0602-XTR,\nMitraClip G4 Clip Delivery System NT CE/CDS0702-NT,\nMitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW,\nMitraClip G4 Clip Delivery System XT CE/CDS0702-XT,\nMitraClip G4 Clip Delivery System XTW CE/CDS0702-XTW,\nMitraClip G4 Clip Delivery Sys NT ROW/CDS0705-NT,\nMitraClip G4 Clip Delivery Sys NTW ROW/CDS0705-NTW,\nMitraClip G4 Clip Delivery Sys XT ROW/CDS0705-XT,\nMitraClip G4 Clip Delivery Sys XTW ROW/CDS0705-XTW,\nTriClip XT Clip Delivery Sys CE/TCDS0202-XT,\nTriClip NT Clip Delivery Sys CE/TCDS0202-NT,\nTriClip XT Clip Delivery Sys ROW/TCDS0205-XT,\nTriClip NT Clip Delivery Sys ROW/TCDS0205-NT,\nTriClip G4 NT Delivery System CE/TCDS0302-NT,\nTriClip G4 NTW Delivery System CE/TCDS0302-NTW,\nTriClip G4 XT Delivery System CE/TCDS0302-XT,\nTriClip G4 XTW Delivery System CE/TCDS0302-XTW,\nTriClip G4 NT Delivery System ROW/TCDS0305-NT,\nTriClip G4 NTW Delivery System ROW/TCDS0305-NTW,\nTriClip G4 XT Delivery System ROW/TCDS0305-XT,\nTriClip G4 XTW Delivery System ROW/TCDS0305-XTW,\nTriClip NT Clip Delivery Sys CE/TCDS0202-NT,\nTriClip NT Clip Delivery Sys ROW/TCDS0205-NT. For cardiac procedures.", "code_info": "Part/UDI-GTIN: CDS0601-NTR/08717648226342,\nCDS0602-NTR/08717648226359,\nCDS0602-XTR/08717648226373,\nCDS0702-NT/08717648230950,\nCDS0702-NTW/08717648230974,\nCDS0702-XT/08717648230998,\nCDS0702-XTW/08717648231018,\nCDS0705-NT/08717648288616,\nCDS0705-NTW/08717648288630,\nCDS0705-XT/08717648288623,\nCDS0705-XTW/08717648288647,\nTCDS0202-XT/08717648229978,\nTCDS0202-NT/08717648229985,\nTCDS0205-XT/08717648288708,\nTCDS0205-NT/08717648288692,\nTCDS0302-NT/08717648334238,\nTCDS0302-NTW/08717648334252,\nTCDS0302-XT/08717648334245,\nTCDS0302-XTW/08717648334269,\nTCDS0305-NT/08717648334313,\nTCDS0305-NTW/08717648334337,\nTCDS0305-XT/08717648334320,\nTCDS0305-XTW/08717648334344,\nTCDS0202-NT/08717648229985,\nTCDS0205-NT/08717648288692\n\nAll lots.", "firm_fei_number": "3004635528", "recalling_firm": "Abbott Vascular", "address_1": "3200 Lakeside Dr", "city": "Santa Clara", "state": "CA", "postal_code": "95054-2807", "additional_info_contact": "Cynthia Kong\n408-845-0883", "reason_for_recall": "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.", "root_cause_description": "Process control", "action": "On 9/8/22, correction notices were distributed to customers who were asked to do the following: \n1) Read and share the information in the notice with all device users.\n2) continue to follow the steps of the IFU (eifu.abbottvascular.com) that is also summarized in the correction notice. It details the most relevant steps to aid in optimal function of the Clip locking mechanism, thereby reducing the probability of EFAA failure and COWL to occur.\n3) Complete and return the Acknowledgement Form.\n4) If you have transferred affected products to other centers, inform those centers of this notice.\n\nThe recalling firm is working on producing new lots with updated manufacturing processing and raw material to mitigate the EFAA/COWL events. They are also using the correction notice to emphasize the most relevant sections of the IFU that can reduce occurrence.\n\nCustomers with questions can contact Customer Service at 1800-544-1664.", "product_quantity": "20,045", "distribution_pattern": "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.", "openfda": { "pma_number": [ "P100009", "P220003" ], "registration_number": [ "2015691", "3019807891", "3015807001", "3020950818", "3017298588", "2024311", "3008500478", "3005070406", "2135147", "3007113487", "3002807314", "3004091615", "3009420598", "3007063218", "2939561", "3005102565", "2011171", "3005941719", "1721676" ], "fei_number": [ "2015691", "3019807891", "3015807001", "3020950818", "3017298588", "2024311", "1713910", "3005334138", "3005070406", "3007113487", "3002807314", "3004091615", "3009420598", "3007063218", "3005102565", "2011171", "3002807111", "3004635528", "1721676" ], "device_name": "Mitral Valve Repair Devices", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }