Smiths Medical Medfusion Model 3500 Syringe Pump Software Defects
Smiths Medical recalls Medfusion Model 3500 syringe pumps (software versions before v6.0.0) due to multiple programming defects that could affect medication delivery rates, timing, and accuracy.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall, indicating reasonable probability the product could cause serious adverse health consequences or death. Software defects directly affecting medication delivery in an infusion pump present serious risks to patient safety regardless of whether specific illnesses have been reported.
Plain-English summary
Smiths Medical is recalling all Medfusion Model 3500 syringe pumps with software versions before v6.0.0 (including v3.X, v4.X, and v5.0.0). Approximately 93,177 affected pumps have been distributed worldwide. These pumps contain multiple software defects that could compromise safe medication delivery.
The specific defects include: medication delivery occurring while the motor is not running with a high-priority alarm; infusions restarting with incorrect parameters; screen lock and auto-lock malfunctions; interruption of bolus or loading dose delivery; incorrect display of bolus or loading dose values; delivery of loading doses below minimum recommended rates; motor rate calculation errors; incorrect recall of saved settings; and configuration file corruption. Each of these defects could affect medication delivery accuracy and timing.
All identified defects have been corrected in software version v6.0.0 (released in 2012) and all subsequent software versions. Healthcare providers and patients using affected pumps should immediately verify their software version and upgrade to v6.0.0 or later. Contact Smiths Medical for technical assistance with upgrading if needed.
The recalled product
- Product
- smiths medical Medfusion Model 3500 Syringe pump
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion pump
- Affected units
- 93,177
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 (2)
- All Medfusion Model 3500 pumps with software v3.X
- v4.X
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · medication delivery error
See all →- ModerateIV Administration Sets and Gravity Infusion Kits Risk Backflow
FDA (Devices) · 2026-04-29
- HighBaxter Infusion Pump Recalled for Incomplete Post-Repair Testing
FDA (Devices) · 2025-01-08
- SevereInfusomat Space Infusion Pump Recall Due to Sensor Malfunction
FDA (Devices) · 2024-09-18
- CriticalMonoject 35 mL Syringe Recalled for Pump Incompatibility Issues
FDA (Devices) · 2023-11-01
- HighAmbulatory infusion pumps recalled due to erroneous software installation
FDA (Devices) · 2022-04-06
Similar recalls
- SevereSmiths Medical Medfusion 4000 Syringe Pump Software Defects Recall
FDA (Devices) · 2024-02-07
- SevereSmiths Medical Medfusion Syringe Pump Recall for Inaccurate Delivery
FDA (Devices) · 2020-08-12
- CriticalSmiths Medical Medfusion Syringe Pump Recall for Inaccurate Dose Delivery
FDA (Devices) · 2020-08-12
- SevereMedfusion Syringe Pump Class I Recall: Risk of Over-Infusion or Therapy Interruption
FDA (Devices) · 2022-06-29
- HighSmiths Medical Medfusion Syringe Pumps May Fail to Recognize Syringes
FDA (Devices) · 2024-04-24
- HighSmiths Medical Medfusion Syringe Pumps Recalled for Syringe Misidentification
FDA (Devices) · 2018-03-28