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  • Device 178
  • Manufacturer 0
  • Event 162
  • Implant 50
SynchroMed® II 8637-20 and 8637-40
  • Model / Serial
  • Product Description
    Alert synchromed implantable pumps
  • Manufacturer
    Medtronic
  • 1 Event
    • Recall of SynchroMed® II 8637-20 and 8637-40
SynchroMed II Implantable Drug Infusion Pump
  • Model / Serial
    SynchroMed II Implantable Drug Infusion Pump ARTG Number: 97770
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of SynchroMed II Implantable Drug Infusion Pump
Extension Tubing in Refill Kits for use with Synchromed pumps
  • Model / Serial
    Extension Tubing in Refill Kits for use with Synchromed pumpsModel number: 8551ARTG number: 133764
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of Extension Tubing in Refill Kits for use with Synchromed pumps
SynchroMed II Model 8637 Implantable Drug Infusion Pump
  • Model / Serial
    SynchroMed II Model 8637 Implantable Drug Infusion PumpARTG Number: 97770
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of SynchroMed II Model 8637 Implantable Drug Infusion Pump
SynchroMed II and SynchroMed EL Implanted Infusion Pump
  • Model / Serial
    SynchroMed II and SynchroMed EL Implanted Infusion PumpAll models and serial numbers affectedARTG Number: 97770
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 2 Events
    • Recall of SynchroMed II and SynchroMed EL Implanted Infusion Pump
    • Recall of SynchroMed II and SynchroMed EL Implanted Infusion Pump
SynchroMed II Implantable Infusion Pump
  • Model / Serial
    SynchroMed II Implantable Infusion Pump ARTG Number: 97770
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of SynchroMed II Implantable Infusion Pump
SynchroMed II and SynchroMed EL Implanted Infusion Pump
  • Model / Serial
    SynchroMed II and SynchroMed EL Implanted Infusion PumpAll models and serial numbersARTG Number: 97770
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of SynchroMed II and SynchroMed EL Implanted Infusion Pump
SynchroMed II Implantable Drug Infusion Pump
  • Model / Serial
    SynchroMed II Implantable Drug Infusion Pump Model Numbers: 8637-20, 8637-40 ARTG Number: 97770
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of SynchroMed II Implantable Drug Infusion Pump
Medtronic SynchroMed II Pumps
  • Model / Serial
    Medtronic SynchroMed II PumpsModel Numbers: 8637-40 and 8637-20Manufactured before July 2011ARTG Number: 97770
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of Medtronic SynchroMed II Pumps
SynchroMed II Infusion System and Model 8870 Software Application Card used in the 8840 N’Vision ...
  • Model / Serial
    SynchroMed II Infusion System and Model 8870 Software Application Card used in the 8840 N’Vision Clinician Programmer SynchroMed II Infusion SystemARTG Number: 977708840 N’Vision Clinician ProgrammerARTG Number: 104700
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd
  • 1 Event
    • Recall of SynchroMed II Infusion System and Model 8870 Software Application Card used in the 8840 N’Vision Clinician Programmer SynchroMed II Infusion System
Synchromed II implantable drug infusion pump
  • Model / Serial
  • Manufacturer
    Medtronic Inc. Minneapolis
  • 2 Events
    • Field Safety Notices about Synchromed II implantable drug infusion pump
    • Field Safety Notices about Synchromed II implantable drug infusion pump
SynchroMed II
  • Model / Serial
  • Manufacturer
    Medtronic
  • 3 Events
    • Field Safety Notices about SynchroMed II
    • Field Safety Notices about SynchroMed II
    • Field Safety Notices about SynchroMed II
Synchromed II pump
  • Model / Serial
  • Manufacturer
    Medtronic
  • 1 Event
    • Field Safety Notices about Synchromed II pump
SynchroMed II
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic
  • 1 Event
    • Field Safety Notices about SynchroMed II
Synchromed
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic
  • 3 Events
    • Field Safety Notices about Synchromed
    • Field Safety Notices about Synchromed
    • Field Safety Notices about Synchromed
SynchroMed Refill Kit
  • Model / Serial
  • Manufacturer
    Medtronic Inc.
  • 1 Event
    • Field Safety Notices about SynchroMed Refill Kit
ISOMED Implantable Infusion Pumps (Mod. 8472-20, 8472-35, 8472-60) and SYNCHROMED II (Mod. 8637-2...
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Inc; Dabasons Imp. Exp. e Comércio Ltda
  • 1 Event
    • 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).
Trade name: Synchromed II Implanted Infusion Pump. Technical Name: Infusion Pump. ANVISA registra...
  • Model / Serial
  • Manufacturer
    Medtronic Comercial Ltda; Medtronic, Inc.
  • 1 Event
    • 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
Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 A...
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Inc.; MEDTRONIC COMERCIAL LTDA
  • 1 Event
    • 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.
Trade name: PROGRAMMER N'VISION MEDTRONIC; Medtronic Implantable Infusion Pump Technical Name: IM...
  • Model / Serial
  • Manufacturer
    MEDTRONIC COMERCIAL LTDA
  • 1 Event
    • 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
Product Affected by Field Action: SynchroMed II Deployable Infusion Pump (Registration 1033919022...
  • Model / Serial
  • Manufacturer
    MEDTRONIC COMERCIAL LTDA; MEDTRONIC INC.
  • 1 Event
    • 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.
SYNCHROMED Implantable Infusion Pump.
  • Model / Serial
  • Manufacturer
    Planta Neuromodulação, Medtronic Inc.; Medtronic Comercial Ltda.
  • 1 Event
    • Safety Alert for SYNCHROMED Implantable Infusion Pump.
APPLICATION CARD OF MODEL 8870 SOFTWARE USED IN MEDICAL PROGRAMMER 8840 N VISION. Related Applian...
  • Model / Serial
  • Manufacturer
    Medtronic Comercial Ltda.
  • 1 Event
    • 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).
MEDTRONIC IMPLANTABLE INFUSION PUMP. Models: SYNCHROMED II 8637-20 and 8637-40; SYNCHROMED EL 862...
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Medtronic Comercial Ltda.
  • 1 Event
    • 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.
SYNCHROMED II Programmable Infusion Pump - ANVISA Registration No. 10099430103.
  • Model / Serial
  • Manufacturer
    MEDTRONIC INC; Dabasons Ltda.
  • 1 Event
    • Safety Alert for SYNCHROMED II Programmable Infusion Pump - ANVISA Registration No. 10099430103.
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