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Recall Observatory FDA recall evidence

Device product

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.

Z-1570-2014

February 26, 2014

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 67720
Status
Terminated
Classification
Class II
Quantity
195,198 pumps (146,435 US, 48,763 OUS)
Official record key
device-enforcement:Z-1570-2014

Official wording

Reason: 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

Code information: This Medical Device Correction notification affects all SynchroMed II pumps.

Distribution pattern: Worldwide Distribution - All states in USA. OUS: List not provided at this time.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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