# FDA recall Z-0117-2023

> **Abbott Vascular** · Class II · device recall initiated 2022-09-08.

## Product

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

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.

## Key facts

- **Recall number:** Z-0117-2023
- **Recalling firm:** Abbott Vascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-08
- **Report date:** 2022-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2023

## Citation

> AI Analytics. FDA recall Z-0117-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0117-2023. Source: US FDA. Licensed CC0.

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