Z-1687-2019Class II

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

Name: Z-1687-2019 Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Creator: Abbott Vascular
Published: 2019-05-01
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2019-05-01 / Terminated

FDA source

Abbott Vascular began a recall of Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only on 2019-05-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1687-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-01
Posted: 2019-05-29
Terminated: 2020-12-11
Recalling firm: Abbott Vascular
Product: Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Product code: NKM Mitral Valve Repair Devices
Reason for recall: 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.
FDA 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.
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
Product codes and lots: All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1687-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1687-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-29

Product code NKM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)