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Open, Classified

Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW. For cardiac procedures.

FDA Recall Z-0115-2023 · Posted 2022-10-20

Recalling FirmAbbott Vascular
Recall StatusOpen, Classified
Product CodeNKM
Date Initiated2022-09-08
Product Quantity18,042

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.

Firm 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.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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