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

FDA device recall Z-1723-2014 · posted 2014-06-04 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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

Action taken

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.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

LKK

Quantity affected

1

Distribution

Distributed in the state of CT.

Date initiated

2014-05-02

Date posted

2014-06-04

Date terminated

2014-10-07

Location

Minneapolis, MN