Medtronic N'Vision 8870 Application Card for use in the… recallZ-1214-2010 · Medtronic Neuromodulation · initiated Mar 23, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1214-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 23, 2009
- Posted by the FDA
- Mar 29, 2010
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 8499 US
- Product code
- LKK
- FDA submissions
- P860004
- Distribution
- All States in the US including DC. OUS: Austria Belgium Croatia Cyprus Czech Republic Denmark Estonia Faroe Islands Finland France French Polynesia Germany Greece Hungary India Ireland Israel Italy Kuwait Lebanon Malta Martinique Netherlands New Caledonia Norway Poland Portugal Reunion Russian Federation San Marino Saudi Arabia South Africa Spain Sweden Switzerland Turkey United Kingdom Vatican City State Canada Mexico Brasil
Product description
Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.
Code information (models, lots, serial numbers)
All model 8870 application cards version AAG, AAJ (English only US & Japan) & BBG (Multi-Language OUS)
Other devices under the same FDA submission
51 devices cleared under P860004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall7 deaths4,929 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
- SYNCHROMED ® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths4,119 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls10 deaths3,054 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths3,084 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls1 death2,588 reports
- SynchroMed® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths2,291 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall3 deaths2,242 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall4 deaths1,964 reports
- SynchroMed® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths1,920 reports
- SYNCHROMED™ III 8667-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 death1,937 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths1,766 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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