Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit,

FDA device recall Z-2172-2014 · posted 2014-08-08 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. There is a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconne

Action taken

Medtronic sent an Urgent Medical Device Removal letter dated July 11, 2014, to all affected customers. The letter described the issue, identified affected product, provided patient management recommendations for patients implanted with an affected device, asked for Risk Management to quaratine unused inventory within the hospital, and to contact Medtronic Customer Service at 1-888-638-7627 to facilitate return of devices.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LKK

Quantity affected

1200 (551 US, 649 OUS)

Distribution

Worldwide Distribution - USA (nationwide) including the states of AL,AR,AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC,

Date initiated

2014-07-11

Date posted

2014-08-08

Date terminated

2015-07-17

Location

Minneapolis, MN