Medtronic SynchroMed II Software Card Recall for Priming Bolus Function
Medtronic is recalling 22,298 SynchroMed II software application cards to update the priming bolus function and pump labeling.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump…"
Plain-English summary
Medtronic Neuromodulation is recalling 22,298 Model 8870 Software Application Cards for the SynchroMed II Implantable Drug Infusion System. The recall involves software cards with versions other than AAU01. The system includes the Model 8840 N'Vision Clinician Programmer and the Model 8637 SynchroMed II Implantable Drug Infusion Pump.
The recall is a follow-up to a May 2013 communication regarding the Priming Bolus function. Medtronic is updating the software application card to version AAU01 and the pump labeling to address this specific issue. The affected products were distributed worldwide, including in the United States, Germany, Greece, Australia, the United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
The SynchroMed II Programmable Pump is indicated for the chronic infusion of specific drugs or fluids, including morphine sulfate, ziconotide, baclofen, floxuridine, or methotrexate. Consumers and healthcare providers should contact Medtronic Neuromodulation for instructions on updating the software and labeling.
The recalled product
- Product
- Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product…
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 22,298
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- software application cards with versions other than AAU01
Distribution
Distributed nationwide across the United States.
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