Z-1723-2014Class II

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

Name: Z-1723-2014 Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal...
Creator: Medtronic Neuromodulation
Published: 2014-05-02
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2014-05-02 / Terminated / root cause: sterility

FDA source

Medtronic Neuromodulation began a recall of Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores... on 2014-05-02. FDA classified it as Class II and gives the reason as "Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1723-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-02
Posted: 2014-06-04
Terminated: 2014-10-07
Recalling firm: Medtronic Neuromodulation
Product: 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.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: There was only one consignee affected by the recall. The consignee was contacted by phone on 5/2/14 and the information was provided verbally. General Manager & Vice President, Pain Stimulation/Targeted Drug Delivery spoke via phone with the physician managing the patient. The following information was provided: "Medtronic identified the potential for endotoxin levels exceeding USP requirements on product recently implanted (Model 8780, serial number N457062003). "There may be the potential for serious patient injury due to endotoxin within the first hours after implant. "Medtronic recommends observing the patient for symptoms of meningitis. Also to be aware that CSF would not test with a positive culture because endotoxin induced meningitis results in an aseptic meningitis. The physician expressed confidence in the management of the patient and stated he was calling the nursing care facility to increase monitoring of the patient. Subsequent information was received regarding the patient indicating there were no signs of an endotoxin reaction.
Quantity in commerce: 1
Distribution: Distributed in the state of CT.
Product codes and lots: N457062003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1723-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1723-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)