FDA Device recall Z-0117-2023
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT R…
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT R… by Abbott Vascular, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0117-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-08 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Vascular |
| Distribution | US |
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
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.
Identifiers
| code_info | Part/UDI-GTIN: CDS0704-NT/08717648234576, CDS0704-NTW/08717648234590, CDS0704-XT/08717648234583, CDS0704-XTW/0871764823…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2023%22
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