FDA-Device2014-05-14Class II
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
Medtronic Neuromodulation
Hazard
This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re
Sold states
Worldwide Distribution - All states in USA. OUS: List not provided at this time.
Affected count
195,198 pumps (146,435 US, 48,763 OUS)
Manufactured in
7000 Central Ave NE, N/A, Minneapolis, MN, United States
Products
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1570-2014Don't want to check this manually?
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