Medtronic Neuromodulation Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
All model 8870 application cards version AAG, AAJ (English only US & Japan) & BBG (Multi-Language OUS)
Products Sold
All model 8870 application cards version AAG, AAJ (English only US & Japan) & BBG (Multi-Language OUS)
Medtronic Neuromodulation is recalling Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. due to Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and u. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of SynchroMed implantable infusion pumps. These errors were most commonly associated with: --Priming Bolus Programming; and --Bridge Bolus Programming. Pump programming errors that result in overdos
Recommended Action
Per FDA guidance
Medtronic is exchanging 8870 versions AAG, AAJ and BBG and replacing it with the updated versions AAH01 and BBH01. The updated versions contain user interface improvements to reduce the chance of user related programming errors when programming SynchroMed II and SynchroMed EL Infusion Pump system. A Medtronic "Medical Device Correction" letter was left behind for consignees. The letter was addressed to "Healthcare Provider" and was dated February 2009. The letter provided information regarding changes to the programming software used in SynchorMed Infusion System. For additional information, please contact your Medtronic Representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026