Smiths Medical recalls Medfusion Syringe Pump models 3500VX-500 v3-v6 due to potential force sensor calibration drift causing false alarms or delayed occlusion detection. Affected units sold before April 2022 may require attention.
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Smiths Medical is recalling Medfusion Syringe Pump models 3500VX-500 v3 through v6 because a force sensor may drift out of calibration. This could cause false occlusion alarms or delay detecting blockages, potentially leading to unsafe medication delivery.
The force sensor in the occlusion detector may drift out of calibration over time, especially in pumps made before April 2022. This could cause false alarms or delay detecting blockages, which might lead to unsafe medication delivery if a blockage occurs.
Patients using these syringe pumps for medical treatments are most at risk. The recall applies to all units sold before April 2022 with specific model numbers.
Check for the model number 3500VX-500 with versions v3, v4, v5, or v6. The recall covers all units sold before April 2022 with specific serial numbers.
Identify the model number and version on your syringe pump to confirm if it is affected.
Reach out to Smiths Medical for guidance on next steps if your pump is affected.
The force sensor in the occlusion detector may drift out of calibration, potentially causing false alarms or delayed detection of blockages in pumps made before April 2022.
No, but you should check if your pump is affected and contact Smiths Medical for guidance.
Contact Smiths Medical for specific instructions on how to proceed with your affected pump.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0077-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0077-2024 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
