Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR — Class II medical device recall Z-0115-2023
Ongoing recall by Abbott Vascular, reported 2022-10-26, distributed nationwide. An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been o
| Recall number | Z-0115-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Santa Clara, CA, United States |
| Recall initiated | 2022-09-08 |
| Classified | 2022-10-20 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 18,042 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08717648226366, 08717648230943, 08717648230967, 08717648230981, 08717648231001 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0115-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.