FDAClass IIOctober 22, 2014

EndoWrist Stapler 45 instrument for the da Vinci Si recall

EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical…

Why was EndoWrist Stapler 45 instrument for the da Vinci Si recalled?

Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

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?

EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.

Product
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical…
Recalling firm
Intuitive Surgical, Inc.
Quantity
1,034 Devices
Distribution
US Nationwide Distribution.
Recall date
October 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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