MitraClip Clip Delivery System recall
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN…
Why was MitraClip Clip Delivery System recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number 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 51207U1
- Product
- MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN…
- Recalling firm
- Abbott Vascular
- Quantity
- 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 Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.
- Recall date
- March 16, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)