Reported Jun 11, 2014 · Terminated

Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is…

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
8780Ascenda Intrathecal Catheter. The implantable Medtronic
8780Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a
8780Ascenda Intrathecal Catheter.
Lot codes and dates
  • N457062003
Amount recalled
1

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 7, 2014 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.