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 o
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Synchromed II Model 8637 programmable pumps that have not been implanted. The pumps come in 20mL and 40mL reservoir sizes and are used to deliver medication to patients. The recall affects 27,547 devices distributed in the United States across all 50 states and Washington, D.C., as well as 13,025 devices distributed outside the United States. The pumps are being recalled because Medtronic implemented a design change to address a potential issue where the motor could stall due to corrosion.
The recall specifically targets devices manufactured with the previous design before the final design change was put in place. Affected consumers can identify recalled devices by checking their product lot or code information against the specific PIN, GTIN, and CFN numbers listed for both U.S. and international distributions. The source document does not specify what action an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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 Quantity: 27,547 US and 13,025 OUS Lot/code info: US: CFN #: GTIN: PIN: 8637-20 00643169508149 863702012H 8637-40 00643169508156 863704012H OUS: CFN#: GTIN : PIN: 8637-20 00643169700901 863700221K 8637-20 00643169700918 863700222K 8637-20 00643169700925 863700223K 8637-20 00643169700932 863700224K 8637-20 00643169700949 863700225K 8637-20 00643169700956 863700226K 8637-20 00643169700963 863700227K 8637-20 00643169700970 863700228K 8637-20 00643169700987 863700229K 8637-20 00643169700994 863700230K 8637-20 00643169732247 863700241K 8637-20 00643169732254 863700242K 8637-20 00643169732261 863700243K 8637-20 00643169732278 863700244K 8637-20 00643169732285 863700245K 8637-20 00643169732292 863700246K 8637-20 00643169732308 863700247K 8637-20 00643169732315 863700248K 8637-20 00643169732322 863700249K 8637-20 00643169732339 863700250K 8637-40 00643169701007 863700231K 8637-40 00643169701014 863700232K 8637-40 00643169701021 863700233K 8637-40 00643169701038 863700234K 8637-40 00643169701045 863700235K 8637-40 00643169701052 863700236K 8637-40 00643169701069 863700237K 8637-40 00643169701076 863700238K 8637-40 00643169701083 863700239K 8637-40 00643169701090 863700240K 8637-40 00643169732346 863700251K 8637-40 00643169732353 863700252K 8637-40 00643169732360 863700253K 8637-40 00643169732377 863700254K 8637-40 00643169732384 863700255K 8637-40 00643169732391 863700256K 8637-40 00643169732407 863700257K 8637-40 00643169732414 863700258K 8637-40 00643169732421 863700259K 8637-40 00643169732438 863700260K
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.