Abbott Vascular Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Brand
Abbott Vascular
Lot Codes / Batch Numbers
All Serial Numbers.
Products Sold
All Serial Numbers.
Abbott Vascular is recalling Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx On due to Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force app. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.
Recommended Action
Per FDA guidance
On 05/01/19, Urgent Medical Device Correction notices were sent to implanting physicians, via personal delivery or email, informing them that under normal use conditions, this failure will not occur. To prevent unintended force from being applied to the clip, revised instructions, including definition and related technique, for performing the steps "Establish Final Angle" and "Invert the Clip Arms" were developed and provided herein. The revised instructions will be applied to the shared XTR and NTR Clip Delivery System Instructions for Use. Unintended excessive force applied to the NTR Clip Delivery System during "Establish Final Arm Angle" can result in unexpected movement of clip arms; however, unlike XTR, the NTR Clip does not become damaged and remains functional. Adhering to the revised IFU sections for both product platforms will ensure consistency of use. Further, the firm requested that customers read the Field Safety Notice, review revised instructions for use with firm representatives, sign and return Effectiveness Check Forms, and share this information with all personnel associated with the procedure. The revised instruction steps provided in this communication will be updated in the product IFU and included in associated training. Your current inventory of product is acceptable for safe use following the revised IFU steps described above. There is no need to return any product. Customers with additional questions are encouraged to call customer service at 800-227-9902.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026