smiths medical Medfusion Model 4000 syringe pump recallZ-0864-2024 · Smiths Medical ASD Inc. · initiated Dec 19, 2023
Class I Open, Classified All recalls posted in February 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.
FDA root cause category: Software Design Change
What the company is doing
Smiths Medical issued an URGENT MEDICAL DEVICE CORRRECTION notice to its consignees on 12/19/2023 by letter delivered via traceable means. This notification details the issues and the affected software versions. Please note that the pump displays the installed software version on the startup screen after the pump is powered on. The notice explained the issues with the pumps, the potential risks involved with their use, and requested the following actions be taken: 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. Please ensure you have the most recent Medfusion software installed on your pumps. 2. Complete and return the attached Response Form to [email protected] within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]. To report adverse events or product complaints: Global Complaint Management, [email protected], 1-(866)-216-8806 Additional information or technical assistance: Technical Support, icumed.custhelp.com/app/market-action Questions about this Field Correction Notice: Field Corrections, icumed.custhelp.com/app/market-action
Recall details
- Recall number
- Z-0864-2024
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Dec 19, 2023
- Posted by the FDA
- Feb 1, 2024
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 60146 pumps
- Product code
- FRN
- FDA submissions
- K111386
- Distribution
- US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia
Product description
smiths medical Medfusion Model 4000 syringe pump
Code information (models, lots, serial numbers)
All Medfusion Model 4000 with software versions: v1.0.0, v1.1.0, v1.1.1, v1.1.2, v1.5.0, v1.5.1, 1.6.0, v1.6.1, v1.6.4, v2.3, v2.4, v2.5, and all versions prior to v1.6.5.
Other devices under the same FDA submission
14 devices cleared under K111386 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medfusion 4000-0106-01Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls4,390 reports
- Medfusion 4000-0105-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2,882 reports
- Medfusion 3500-0600-01Icu Medical, Inc. · Pump, infusion2 recalls2,041 reports
- Medfusion 4000-0101-51Icu Medical, Inc. · Pump, infusion2 recalls1 death1,795 reports
- Medfusion 3500-0600-82Icu Medical, Inc. · Pump, infusion2 recalls89 reports
- MEDFUSION 4000-0106-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls10 reports
- Medfusion 3500-0600-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls9 reports
- MEDFUSION 4000-0106-231Icu Medical, Inc. · Pump, infusion2 recalls5 reports
- Medfusion 3500-0600-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2 reports
- Medfusion 4000-0105-249Icu Medical, Inc. · Pump, infusion2 recalls1 report
- Medfusion 4000-0105-78Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls0 reports
- MEDFUSION 4000-0107-01Icu Medical, Inc. · Pump, infusion1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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