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Name Date Date initiated Country Source
Recall of Device Recall SynchroMed II Implantable Drug Infusion Pump 2014-02-26 United States USFDA
Recall of Device Recall Ascenda Intrathecal Catheter 2014-07-11 United States USFDA
Safety Alert Or Field Safety Notices for SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 implantable drug pumps 2008-12-18 United Kingdom MHRA
Safety Alert Or Field Safety Notices for SynchroMed® implantable drug pump 2003-10-22 United Kingdom MHRA
Safety Alert Or Field Safety Notices for Implantable drug pumps and accessories 2013-06-19 United Kingdom MHRA
Safety Alert for N VISION MEDTRONIC PROGRAMMER - Model 8870 Application Software Cards used with N Vision Clinician Programmers Model 8840, Reg # 10339190180. 2004-09-24 Brazil ANVISA
Safety Alert for ISOMED Implantable Infusion Pumps (Mod. 8472-20, 8472-35, 8472-60) and SYNCHROMED II (Mod. 8637-20 and 8637-40). Anvisa registration number: 10099430095 (ISOMED) and 10099430103 (SYNCHROMED II). 2008-05-20 Brazil ANVISA
Safety Alert for MEDTRONIC IMPLANTABLE INFUSION PUMP. Models: SYNCHROMED II 8637-20 and 8637-40; SYNCHROMED EL 8626-10, 8626L-10, 8626-18, 8626L-18; SYNCHROMED EL 8627. Anvisa Registries No. 10339190229, 10339190104 and 10339190105. 2012-11-27 Brazil ANVISA
Safety Alert for APPLICATION CARD OF MODEL 8870 SOFTWARE USED IN MEDICAL PROGRAMMER 8840 N VISION. Related Appliances: SYNCHROMED II IMPUTABLE INFUSION PUMP (10339190229); ACTIVE PROGRAMMABLE NEUROSTIMULATOR (10339190338); MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (10339190310); PROGRAMMER N`VISION MEDTRONIC (10339190180). 2013-10-04 Brazil ANVISA
Safety Alert for SYNCHROMED Implantable Infusion Pump. 2015-05-15 Brazil ANVISA
Safety Alert for Product Affected by Field Action: SynchroMed II Deployable Infusion Pump (Registration 10339190229) Models 8637-20, 8637-40 - Risk Class IV. DISTRIBUTION MAP IN ANNEX. 2016-02-29 Brazil ANVISA
Safety Alert for Trade name: PROGRAMMER N'VISION MEDTRONIC; Medtronic Implantable Infusion Pump Technical Name: IMPLANTABLE DEVICE PROGRAMMER; Infusion Pump ANVISA registration number: 10339190180; 10339190229 Hazard Class: III; IV Model affected: 8840; Synchromed II 8637-20 / Synchromed II 8637-40 2016-12-22 Brazil ANVISA
Safety Alert for Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 ANVISA Registration Number: 10339190229 Hazard Class: IV Affected Model: 8637-20 and 8637-40 Serial Numbers Affected: PUMP 8637 -20 SM2 20ML EMAN US JUN BATRY; PUMP 8637-20 SM2 20ML PAP MAN US JUN BAT; PUMP 8637-20 SM2 20ML PAPER MAN USMKT SL; PUMP 8637-20 SM2 20ML PAPR MAN USMKTJUNC PUMP 8637-20 SYNCH II 20ML US MKT SL; PUMP 8637-20 SYNCHMED II 20ML PF; PUMP 8637-20 SYNCHMED II PCKT FILL L105; PUMP 8637-20 SYNCHROMED II L089; PUMP 8637-20 SYNCHROMED II OUS L105; PUMP 8637-40 SYNCHMED II PCKT FILL L105; PUMP 8637-40 SYNCHROMED II L089; PUMP 8637-40 SYNCHROMED II OUS L105. 2017-04-12 Brazil ANVISA
Safety Alert for Trade name: Synchromed II Implanted Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 10339190229. Risk class: IV. Model affected: 8637-20 E 8637-40. Affected serial numbers: See Distribution list and Batch Affected 2017-11-17 Brazil ANVISA
Field Safety Notices about implantable infusion pumps synchromed ii 2017-11-27 Poland ORMPMDBP
Field Safety Notices about implantable infusion pumps synchromed ii 2016-03-16 Poland ORMPMDBP
Field Safety Notices about implantable synchromed infusion pump 2013-06-13 Poland ORMPMDBP
Field Safety Notices about implantable synchromed infusion pump 2013-06-14 Poland ORMPMDBP
Field Safety Notices about implantable synchromed infusion pump 2013-06-13 Poland ORMPMDBP
Field Safety Notices about implantable synchromed infusion pumps. 2011-01-24 Poland ORMPMDBP
Field Safety Notices about implanted infusion pumps synchromed ii 2016-11-14 Poland ORMPMDBP
Field Safety Notices about infusion pump synchromed ii model 8637 2017-05-18 Poland ORMPMDBP
Field Safety Notices about infusion pumps synchromed ii. 2012-03-21 Poland ORMPMDBP
Field Safety Notices about implantable infusion pumps synchromed ii - models 8637-20, 8637-40 2008-06-13 Poland ORMPMDBP
Field Safety Notices about intrathecal catheters, models 8709sc, 8731sc, 8596sc, 8578, with implantable infusion pumps synchromed® and isomed® 2008-06-24 Poland ORMPMDBP