Z-1568-2014Class II

Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable...

Name: Z-1568-2014 Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable...
Creator: Medtronic Neuromodulation
Published: 2014-04-04
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2014-04-04 / Terminated / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are... on 2014-04-04. FDA classified it as Class II and gives the reason as "Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1568-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-04
Posted: 2014-05-08
Terminated: 2014-11-05
Recalling firm: Medtronic Neuromodulation
Product: Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic sent a "Medical Device Removal" letter dated April 2014 hand delivered, e-mail or faxed to affected customers. The letter described the problem and the product affected by the recall. The letter also contained the Action Required, Additional Information (Contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm Central Time) and requested consignees to complete and fax or e-mail the "Medical Device Removal Reply Form".
Quantity in commerce: 13,784
Distribution: Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
Product codes and lots: Lot numbers CS3643, CS3613, CS3663, N441998, N442081, N442131, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N442178, N442513, N442532, N442560, N442588, N442831, and N443427. Affected lots were distributed between January 2014 and March 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1568-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1568-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-08

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)