MitraClip Clip Delivery System — Class I medical device recall Z-0911-2016
Terminated recall by Abbott Vascular, reported 2016-03-16, distributed nationwide. Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Wa
| Recall number | Z-0911-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Temecula, CA, United States |
| Recall initiated | 2016-02-04 |
| Classified | 2016-03-07 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IT, KW, LU, MX, MY, NL, NO, NZ, PH, PL, PT, RO, SA, SE, SI, TH, TR, VN |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08717648195914, 08717648195921 |
| Lot numbers | 50811U1, 50811U2, 50812U1, 50813U1, 50814U1, 50826U1, 50826U2, 50827U1, 50908U1, 50908U2, 50909U1, 50910U1, 50910U2, 50911U1, 50924U1, 50925U1, 50928U1, 50929U1, 51010U1, 51012U1, 51012U2, 51013U1, 51014U1, 51014U2, 51026U1, 51027U3, 51028U1, 51028U2, 51029U1, 51030U1, 51105U1, 51106U1, 51109U1, 51109U2, 51110U1, 51110U2, 51117U1, 51203U1, 51204U1, 51205U1 and 1 more |
Product
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.
Reason for recall
Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.
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-0911-2016. 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.