Abbott Vascular: Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

Recall number

Z-1687-2019

Recalling firm

Abbott Vascular

Product

Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only

Status

Terminated

Initiated

2019-05-01

Posted

not on file

Terminated

2020-12-11

Reason

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.

Root cause

Use error

Action

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.

Quantity

not on file

Distribution

U.S.: FL, UT, IN, OK, TX, CO, LA, AZ, MO, AL, GA, CA, AR, KS, IL, HI, IA, KY, MA, DC, NY, NV, NM, NJ, MT, MD, NC, CT, MI, MN, OH, ND, NH, OR, PA, WI, WA, VA, WV, TN, SC, RI, DE, ME, NE, SD, MS, ID, VT. Foreign (OUS): AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, Canada, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MACAU, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED KINGDOM

Lot, serial or model codes

All Serial Numbers.

510(k) numbers

not on file

PMA numbers

["P100009S025"]

Product code

NKM

Firm FEI

2024168

Firm city

Temecula

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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