Iradimed MRidium Dose Reduction System Recall for Infusion Rate Errors
Iradimed is recalling MRidium 1145 Dose Reduction System kits because they may display incorrect infusion rates, posing a risk of over- or under-infusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (over- or under-infusion) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Iradimed Corporation is recalling 176 units of the MRidium 1145 Dose Reduction System (DERS) drug library kit. This kit is an option for the MRidium 3860+MR Infusion Pump System, which is intended for general hospital or clinical use by medical professionals to infuse patients with intra-venous or intra-arterial fluids before, during, or after magnetic resonance imaging (MRI) scans.
The recall is due to a defect where the DERS can indicate an incorrect recommended value for the infusion rate via a specific key sequence during the initial setup. If an infusion is started with this incorrect rate value, it can result in a risk of over-infusion or under-infusion.
The affected kits were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, Austria, Denmark, France, Germany, the Netherlands, Saudi Arabia, and the United Kingdom. The recall includes specific part number 1145 lots ranging from 4501 to 7213. Medical professionals should stop using the affected kits and contact Iradimed Corporation for further instructions.
The recalled product
- Product
- MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patient
- Manufacturer
- Iradimed Corporation
- Affected units
- 176
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 (20)
- Part number 1145 Lots: 4501
- 4510
- 4538
- 4587
- 4596
- 4675
- 4690
- 4705
- 4738
- 4748
- 4960
- 4970
- 5001
- 5065
- 5104
- 6164
- 5221
- 5240
- 5349
- 5361
Distribution
Related recalls
Same manufacturer · Iradimed Corporation
See all →- HighIradimed MRidium MRI Infusion Pump Syringe Adapter Sets Recalled for Occlusion Risk
FDA (Devices) · 2023-04-05
- ModerateIradimed Recalls MRidium Series 1000 MR Infusion Sets Due to Specification Defect
FDA (Devices) · 2012-12-05
Same hazard · infusion error
See all →- SevereIvenix Infusion System software recalled for pump malfunction risk
FDA (Devices) · 2025-02-12
- HighInfusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts
FDA (Devices) · 2021-05-19
- HighStep-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts
FDA (Devices) · 2021-05-19
- HighAftermarket Alaris Infusion Pump Front Bezel Recall for Potential Infusion Errors
FDA (Devices) · 2021-04-28
- HighTenacore Alaris Infusion Pump Bezel Recall for Cracking Risk
FDA (Devices) · 2021-04-14