Medtronic Neuromodulation recalls Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implant…

Recall date

August 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0896-2018

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).