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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 69 Results
PMA Number: P860004
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SynchroMed II implantable drug infusion pump, Model 8637-40, 2 Mar-29-2017 Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Softwar... 1 Dec-19-2016 Medtronic Neuromodulation
Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide. 2 Mar-29-2016 Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product... 2 May-28-2015 Medtronic Neuromodulation
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump S... 2 Aug-08-2014 Medtronic Neuromodulation
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda I... 2 Jun-04-2014 Medtronic Neuromodulation
Medtronic SynchroMed® II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable ... 2 May-08-2014 Medtronic Neuromodulation
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Progra... 2 May-08-2014 Medtronic Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir... 1 Jun-25-2013 Medtronic Neuromodulation
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pump... 1 Jun-25-2013 Medtronic Neuromodulation