Z-1384-04

The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access...

Name: Z-1384-04 The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access...
Creator: Medtronic Inc, Neurological & Spinal Division
Published: 2004-07-23
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2004-07-23 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc, Neurological & Spinal Division began a recall of The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable... on 2004-07-23. The reason FDA records is "The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1384-04
Status: Terminated
Initiated: 2004-07-23
Posted: 2004-08-24
Terminated: 2005-11-23
Recalling firm: Medtronic Neuromodulation
Product: The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of manufactured product: CS0293.
Quantity in commerce: 405 kits
Distribution: US and one customer in New Zealand.
Product codes and lots: CS0293

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)