FDAClass IIJune 11, 2014

Medtronic recall: Endotoxin

Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system…

Why was Medtronic recalled?

Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

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?

N457062003

Product
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system…
Recalling firm
Medtronic Neuromodulation
Quantity
1
Distribution
Distributed in the state of CT.
Recall date
June 11, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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