Iradimed 1057Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00856038001041), received between Mar 21, 2023 and Apr 6, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Defective Component” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K050301); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 24, 2023Open, Classified

   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.

   Z-1310-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Defective Component; No Flow; Suction Failure; Defective Component; No Flow; Suction Failure

  CUSTOMER INDICATED IN THEIR RESPONSE TO RECALL Z-1310-2023 THAT THEY HAD OBSERVED THE PROBLEM DESCRIBED IN THE RECALL. NO PATIENT INJURY WAS REPORTED, BUT THIS RESPONSE IS BEING TREATED AS A NEW PRODUCT DEFECT REPORT SINCE IRADIMED WAS NOT AWARE OF THIS CUSTOMER'S ISSUE PRIOR TO THEIR RECALL RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693897 ↗
• MalfunctionApr 6, 2023Defective Component; No Flow; Suction Failure; Defective Component; No Flow; Suction Failure

  CUSTOMER INDICATED IN THEIR RESPONSE TO RECALL Z-1310-2023 THAT THEY HAD OBSERVED THE PROBLEM DESCRIBED IN THE RECALL. NO PATIENT INJURY WAS REPORTED, BUT THIS RESPONSE IS BEING TREATED AS A NEW PRODUCT DEFECT REPORT SINCE IRADIMED WAS NOT AWARE OF THIS CUSTOMER'S ISSUE PRIOR TO THEIR RECALL RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693859 ↗
• MalfunctionApr 6, 2023Defective Component; No Flow; Suction Failure; Defective Component; No Flow; Suction Failure

  CUSTOMER INDICATED IN THEIR RESPONSE TO RECALL Z-1310-2023 THAT THEY HAD OBSERVED THE PROBLEM DESCRIBED IN THE RECALL. NO PATIENT INJURY WAS REPORTED, BUT THIS RESPONSE IS BEING TREATED AS A NEW PRODUCT DEFECT REPORT SINCE IRADIMED WAS NOT AWARE OF THIS CUSTOMER'S ISSUE PRIOR TO THEIR RECALL RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693856 ↗
• MalfunctionMar 21, 2023Defective Component; No Flow; Suction Failure; Defective Component; No Flow; Suction Failure

  IT WAS REPORTED THAT THERE WAS A RESTRICTION IN THE SILICONE TUBING CAUSING NO FLUID TO FLOW. IT WAS LATER CONFIRMED THAT THIS WAS RELATED TO THE ISSUE WITH THE SYRINGE VENT BLOCKAGE. THIS ISSUE WAS CAUSING INLET OCCLUSIONS AND THE SILICONE TO COLLAPSE WHEN THE PUMP CREATED A VACUUM IN THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585752 ↗
• MalfunctionMar 21, 2023Suction Problem; Defective Component; No Flow; Suction Problem; Defective Component; No Flow

  IT WAS REPORTED THAT THE VENT WAS NOT ALLOWING AIR INTO THE LINE FOR A SET FROM LOT 22J46N AND THE SILICONE SECTION WAS COLLAPSING DUE TO VACUUM BEING FORMED WHEN PUMPING. NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585712 ↗
• MalfunctionMar 21, 2023Defective Component; No Flow; Suction Failure; Defective Component; No Flow; Suction Failure

  IT WAS REPORTED THAT LOT 2246JN OF A 1057 SET IS NOT ALLOWING AIR TO FLOW INTO THE SET AND CAUSING THE SILICONE SECTION OF THE TUBING TO COLLAPSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585668 ↗
• MalfunctionMar 21, 2023Defective Component; No Flow; Suction Failure; Defective Component; No Flow; Suction Failure

  IT WAS REPORTED THAT A CUSTOMER HAD FAULTY 1057 SETS. THE SETS WERE THROWN AWAY, AND THE PACKAGING IS NO LONGER AVAILABLE, SO THE LOT# IS UNKNOWN. THE CUSTOMER ALSO INDICATED THEY WERE GETTING INLET OCCLUSION ALARMS WITH SOME OF THE SETS. THE ISSUE WAS LATER CONFIRMED TO BE RELATED TO LOT 22J46N.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050301. One submission often covers many models, so check the product and lot details in each record.

• Z-0446-2013 · Aug 24, 2012 · Terminated
  The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml