Medtronic Neuromodulation: Medical Device Recall in 2014 - (Recall #: Z-1568-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 4, 2014

Date Posted: May 14, 2014

Recall Number: Z-1568-2014

Event ID: 68031

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.

Status: Terminated

Product Quantity: 13,784

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated