SYNCHROMED II recallZ-0896-2018 · Medtronic Neuromodulation · initiated Aug 9, 2017
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0896-2018
- Status
- Open, Classified
- Initiated by the company
- Aug 9, 2017
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 27,547 US and 13,025 OUS
- Product code
- LKK
- FDA submissions
- P860004
- 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
Product description
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).
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls10 deaths3,054 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls1 death2,588 reports
Product lines
Other devices under the same FDA submission
49 devices cleared under P860004 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall7 deaths4,929 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
- SYNCHROMED ® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths4,119 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths3,084 reports
- SynchroMed® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths2,291 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall3 deaths2,242 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall4 deaths1,964 reports
- SynchroMed® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths1,920 reports
- SYNCHROMED™ III 8667-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 death1,937 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths1,766 reports
- SYNCHROMED®II 8637-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall2 deaths1,646 reports
- SYNCHROMED®II 8637-40Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall3 deaths1,478 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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