Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump
Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error that prevented updates but did not result in reported injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Neuromodulation is recalling one unit of the SynchroMed II implantable drug infusion pump, Model 8637-40, with serial number NGV526743H. The device was distributed in Illinois.
The recall was initiated after Medtronic received a complaint that an error code appeared on the programmer when a physician attempted to interrogate the implanted pump. This error code prevented the physician from updating the pump, although the pump continued to provide therapy.
Patients with this specific device should contact their physician or Medtronic for further instructions regarding the recall.
The recalled product
- Product
- SynchroMed II implantable drug infusion pump, Model 8637-40,
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 1
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)
- Serial Number NGV526743H
Distribution
Distributed in 1 state:
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