Recall Z-1570-2014— Medtronic Neuromodulation
Class II · Terminated
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2014-02-26, terminated 2018-09-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-26
- Terminated
- 2018-09-28
- Firm location
- Minneapolis, MN, United States
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.