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

FDA device recall Z-1568-2014 · posted 2014-05-08 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

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.

Action taken

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".

Root cause

Process control

Status

Terminated

Product code

LKK

Quantity affected

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.

Date initiated

2014-04-04

Date posted

2014-05-08

Date terminated

2014-11-05

Location

Minneapolis, MN