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U.S. Department of Health and Human Services

Class 2 Device Recall MitraClip" and TriClip" Delivery System(s)

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  Class 2 Device Recall MitraClip" and TriClip" Delivery System(s) see related information
Date Initiated by Firm September 08, 2022
Date Posted October 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0117-2023
Recall Event ID 90840
Product Classification Mitral valve repair devices - Product Code NKM
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.
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.
Recalling Firm/
Manufacturer
Abbott Vascular
3200 Lakeside Dr
Santa Clara CA 95054-2807
For Additional Information Contact Cynthia Kong
408-845-0883
Manufacturer 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.
FDA Determined
Cause 2
Process control
Action On 9/8/22, correction notices were distributed to customers who were asked to do the following: 1) Read and share the information in the notice with all device users. 2) 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. 3) Complete and return the Acknowledgement Form. 4) If you have transferred affected products to other centers, inform those centers of this notice. The 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. Customers with questions can contact Customer Service at 1800-544-1664.
Quantity in Commerce 767
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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