Summary
The FDA issued a Class II for SynchroMed II Infusion Pump. Product Number: 8637-20 by Medtronic Neuromodulation. Reason: Potential for error and inability to interrogate pump due to data corruption in the pump memory..
Details
Source
Device Recall
External ID
Z-0137-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
Product Description
SynchroMed II Infusion Pump. Product Number: 8637-20
Lot/Code Info: GTIN Number: 00643169630505. Serial Number: NGP004814H
Quantity Affected: 1 unit
Reason for Recall
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Distribution
US Nationwide distribution in the state of Mississippi.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-11
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0137-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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