FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: 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.
- Recall number
- Z-1723-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-05-02
- Posted
- 2014-06-04
- Terminated
- 2014-10-07
- Reason
- Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.
- 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
- 1
- Distribution
- Distributed in the state of CT.
- Lot, serial or model codes
- N457062003
- 510(k) numbers
- not on file
- PMA numbers
- ["P860004S125"]
- Product code
- LKK
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28