Iradimed MRidium Infusion Set (Iradimed) - Adapter Defect (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Brand
Iradimed Corporation
Lot Codes / Batch Numbers
UDI di 10856038001048, Lot Numbers: 21K50N, exp. 11/30/2023, 22A03N, exp. 01/31/2024, 22A59N, exp. 2/29/2024, 22B54N, exp. 2/29/2024, 22D15N, exp. 4/30/2024, 22D28N, exp. 4/30/2024, 22D58N, exp. 4/30/2024, 22I17N, exp. 9/30/2024, 031851, exp. 9/30/2024, 22J46N, exp. 10/31/2024, 032198, exp. 11/30/2024, 22L02N, exp. 12/31/2024, 032822, exp. 1/31/2025
Products Sold
UDI di 10856038001048, Lot Numbers: 21K50N, exp. 11/30/2023; 22A03N, exp. 01/31/2024; 22A59N, exp. 2/29/2024; 22B54N, exp. 2/29/2024; 22D15N, exp. 4/30/2024; 22D28N, exp. 4/30/2024; 22D58N, exp. 4/30/2024; 22I17N, exp. 9/30/2024; 031851, exp. 9/30/2024; 22J46N, exp. 10/31/2024; 032198, exp. 11/30/2024; 22L02N,exp. 12/31/2024; 032822, exp. 1/31/2025
Iradimed Corporation is recalling Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, due to Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part whic. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.
Recommended Action
Per FDA guidance
Iradimed Corporation issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/24/2023 by certified mail. The notice explained the issue and the risk and provided updated instructions for use to mitigate the potential risk of inlet occlusion. For further information concerning this issue or have any questions, please contact Iradimed support via email at SyringeAdapterRecall@Iradimed.com or via telephone at 407-677-8022.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026