Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, Mitr

FDA device recall Z-0116-2023 · posted 2022-10-20 · Open, Classified

Recall details

Recalling firm

Abbott Vascular

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.

Action taken

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

Status

Open, Classified

Product code

NKM

Quantity affected

20,045

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

Date initiated

2022-09-08

Date posted

2022-10-20

Location

Santa Clara, CA