Reported Mar 14, 2018 · Ongoing
Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
8637 | supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable |
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 |
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). |
- Lot codes and dates
42 of 42 products
Products covered by this recall Model / number Barcodes Product as published 8637-2000643169508149863702012H 8637-4000643169508156863704012H OUS: CFN#: GTIN : PIN 8637-2000643169700901863700221K 8637-2000643169700918863700222K 8637-2000643169700925863700223K 8637-2000643169700932863700224K 8637-2000643169700949863700225K 8637-2000643169700956863700226K 8637-2000643169700963863700227K 8637-2000643169700970863700228K 8637-2000643169700987863700229K 8637-2000643169700994863700230K 8637-2000643169732247863700241K 8637-2000643169732254863700242K 8637-2000643169732261863700243K 8637-2000643169732278863700244K 8637-2000643169732285863700245K 8637-2000643169732292863700246K 8637-2000643169732308863700247K 8637-2000643169732315863700248K - Amount recalled
- 27,547 US and 13,025 OUS
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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