Z-0115-2023Class II

Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT...

Name: Z-0115-2023 Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT...
Creator: Abbott Vascular
Published: 2022-09-08
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2022-09-08 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Vascular began a recall of 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... on 2022-09-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0115-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-08
Posted: 2022-10-20
Recalling firm: Abbott Vascular
Product: 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.
Product code: NKM Mitral Valve Repair Devices
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 18,042
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, 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.
Product codes and lots: Part/UDI: CDS0601-XTR/08717648226366, CDS0701-NT/08717648230943, CDS0701-NTW/08717648230967, CDS0701-XT/08717648230981, CDS0701-XTW/08717648231001, All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0115-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0115-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0116-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0117-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20

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)