Abbott MitraClip XTR Clip Delivery System — Class II medical device recall Z-1687-2019
Terminated recall by Abbott Vascular, reported 2019-06-05, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resul
| Recall number | Z-1687-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Temecula, CA, United States |
| Recall initiated | 2019-05-01 |
| Classified | 2019-05-29 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2020-12-11 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, AU, BE, BG, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IT, KW, LB, NL, NO, NZ, PL, PT, RO, RU, SA, SE, SG, SK, TH, TR |
| UPC / GTIN / UDI-DI | 08717648226366 |
| Model numbers | CDS0601-XTR |
Product
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
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.
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-1687-2019. 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.