FDAFebruary 4, 2016device
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 maj...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
abbott vascularabbott
UPCs
0871764819591408717648195921
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
- FDAArtegraft Vascular Graft; REF#: AG740;2026-02-10
- FDAProduct Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable2026-02-09
- FDABroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 600602025-12-12
- FDAFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
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