SynchroMed II Infusion Pump Recalled Due to Memory Data Corruption
Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The hazard—data corruption preventing device interrogation—poses significant risk in a critical medical device but has not yet resulted in confirmed harm. Per the severity rubric, this constitutes a high-risk product where injury has not yet been reported.
Plain-English summary
The SynchroMed II Infusion Pump, Product Number 8637-20, manufactured by Medtronic Neuromodulation, is being recalled. The recall is due to potential data corruption in the device's memory that can cause errors and prevent the pump from being interrogated properly.
The device has been distributed throughout the United States. Patients who use this pump and their healthcare providers should be aware of this recall.
Patients should contact Medtronic Neuromodulation for information and guidance regarding this recall.
The recalled product
- Product
- SynchroMed II Infusion Pump. Product Number: 8637-20
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Infusion Pump
- 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)
- GTIN Number: 00643169630505. Serial Number: NGP004814H
Distribution
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