Recall Z-0896-2018— Medtronic Neuromodulation

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2017-08-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).. Reason: Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted..

Recalling firm

Medtronic Neuromodulation

Classification

Class II

Status

Ongoing

Initiated

2017-08-09

Firm location

Minneapolis, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.