MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product

FDA device recall Z-0911-2016 · posted 2016-03-07 · Terminated

Recall details

Recalling firm

Abbott Vascular

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.

Action taken

The firm, Abbott Vascular, sent an "URGENT FIELD SAFETY NOTICE/MITRACLIP/CORRECTION" letter dated 2/4/16 to all the customers who received the MitraClip System. The letter described the product, problem and actions to be taken. The Customers are informed that their inventory is acceptable for safe use following the revised IFU steps described in the customer notification letter and that there is no need for the customers to return any product to Abbott Vascular. Customers with questions are instructed to contact their local Abbott Vascular representative.Customers were also instructed complete and return a Training Form/Effectiveness Check via their Abbott Vascular Representative, fax to 1-951-914-5951 or scan and email to AVRegulatoryCompliance@av.abbott.com. The firm is revising the IFU to incorporate the revised procedural steps. A press release dated 2/26/16 will be posted on the firm's website to inform the public that Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. Customers with questions or concerns are instructed to contact Abbott Vascular Representative or call Abbott Vascular at (800) 227-9902.

Root cause

Use error

Status

Terminated

Product code

NKM

Quantity affected

7,600 units total (2,300 units in US)

Distribution

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia P

Date initiated

2016-02-04

Date posted

2016-03-07

Date terminated

2016-05-12

Location

Temecula, CA