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Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR ...

FDA Device Recall #Z-0117-2023 — Class II — September 8, 2022

Recall Summary

Recall Number Z-0117-2023
Classification Class II — Moderate risk
Date Initiated September 8, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Vascular
Location Santa Clara, CA
Product Type Devices
Quantity 767

Product Description

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.

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.

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.

Lot / Code Information

Part/UDI-GTIN: CDS0704-NT/08717648234576, CDS0704-NTW/08717648234590, CDS0704-XT/08717648234583, CDS0704-XTW/08717648234606, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961, TCDS0303-NT/08717648334276, TCDS0303-NTW/08717648334290, TCDS0303-XT/08717648334283, TCDS0303-XTW/08717648334306, TCDS0203-NT/08717648229992, TCDS0203-XT/08717648229961 All lots.

Other Recalls from Abbott Vascular

Recall # Classification Product Date
Z-0115-2023 Class II Product/Part: MitraClip XTR Clip Delivery Syste... Sep 8, 2022
Z-0116-2023 Class II Product/Part: MitraClip NTR Clip Delivery Syste... Sep 8, 2022
Z-1095-2022 Class I Dragonfly OpStar Imaging Catheter, REF 1014651/... Mar 30, 2022
Z-0921-2022 Class II 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (20... Mar 11, 2022
Z-0924-2022 Class II INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 ... Mar 11, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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