Medtronic SynchroMed Programmer Application Software Recall, Type II
Summary
Health Canada has issued a Type II recall for Medtronic's SynchroMed Clinician Programmer Application (CP app) model A810 due to a software sequencing issue affecting flex dosing programming for SynchroMed 8637 and 8667 infusion pumps. When flex dosing steps are added overlapping and out of chronological order, the app may fail to reorder them correctly, potentially causing infusion steps to be delivered at incorrect times, leading to missed doses, underdosing, or shifted dose timing without immediate alerts. Eleven complaints have been reported globally. Affected parties should contact Medtronic for information and guidance.
What changed
Health Canada has recalled Medtronic's SynchroMed Clinician Programmer Application (A810) due to a software sequencing issue in the flex dosing feature. When flex dosing steps are added overlapping and out of chronological order, the application may fail to reorder them correctly, resulting in infusion steps being delivered at incorrect times. This can cause missed flex doses, underdosing, or shifts in dose timing with no immediate alerts to the user. The issue affects only flex dosing mode and does not impact other infusion modes. Eleven complaints have been reported globally.
Healthcare providers using Medtronic SynchroMed 8637 and 8667 pumps with the A810 Clinician Programmer Application should contact Medtronic for guidance and monitor for any unexpected dosing irregularities. This Type II recall indicates moderate potential for harm and requires attention but is not classified as an immediate safety threat requiring device removal.
What to do next
- Contact Medtronic for additional information on the recall
- Report any health or safety concerns to Health Canada
- Monitor for updates from Medtronic regarding software remediation
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
SynchroMed Clinician Programmer Application
Brand(s)
Last updated
2026-04-15
Summary
Product SynchroMed Clinician Programmer Application Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| SynchroMed Clinician Programmer Application | More than 10 numbers, contact manufacturer. | A810 |
Issue
Complaint investigations identified a software sequencing issue in the Medtronic A810 SynchroMed Clinician Programmer Application (CP app), specifically affecting flex dosing when programming the SynchroMed 8637 and 8667 pumps. When flex dosing steps are added overlapping and then out of chronological order, the app may fail to reorder them correctly, resulting in infusion steps being delivered at incorrect times. This can lead to missed flex doses, underdosing, or shifts in dose timing, and no immediate alerts. The issue is limited to flex dosing and does not impact other infusion modes. Eleven (11) complaints have been reported globally related to this issue.
Additional information
Details
Original published date:
2026-04-15
Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies
| Medtronic Inc. |
| 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432 |
Published by Health Canada Audience General public Healthcare Recall class Type II Recall date
2026-04-08
Identification number RA-81898
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