Reported Mar 16, 2016 · Terminated
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product…
Abbott Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
- Lot number
50811U150811U250812U150813U150814U150826U150826U250827U150908U150908U250909U150910U150910U250911U150924U150925U150928U150929U151010U151012U151012U251013U151014U151014U251026U151027U351028U151028U251029U151030U151105U151106U151109U151109U251110U151110U251117U151203U151204U151205U151207U1
- Lot number
- Amount recalled
- 7,600 units total (2,300 units in US)
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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