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).
FDA Recall Z-0896-2018 · Posted None
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Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeLKK
Date Initiated2017-08-09
Product Quantity27,547 US and 13,025 OUS
Reason for Recall
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.
Firm Action
Medtronic sent an Urgent Medical Device Recall letter dated September 2017, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed Customers Confirmation form. For questions contact Technical Services at 1-888-854-0978.
Root Cause
Device Design
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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