CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report

Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable recalled

Medtronic Neuromodulation is recalling Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable, distributed in Connecticut. The recall was initiated on 2 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN457062003

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1723-2014
FDA event ID: 68295
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 2 May 2014
FDA classified: 4 Jun 2014
Reported: 11 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

2 May 2014	Recall initiated by company
4 Jun 2014	Classified by FDA	+33 days
11 Jun 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Distributed in the state of CT.

Connecticut

Questions about this recall

Why was it recalled?

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

Which lots are affected?

N457062003

Where was it sold?

Distributed in the state of CT.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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