MEDRAD® MRXperion Sterile Disposable MRI Kit XP 65/115VSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00616258021690), received between Mar 11, 2021 and Mar 10, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K143538); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING AN XP 65/115VS DISPOSABLE SYRINGE KIT A FOREIGN MATERIAL WAS VISUALIZED IN THE TUBING. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720530 ↗
• MalfunctionMar 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING AN XP 65/115VS DISPOSABLE SYRINGE KIT A FOREIGN MATERIAL WAS VISUALIZED IN THE TUBING. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464333 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143538. One submission often covers many models, so check the product and lot details in each record.

• Z-2244-2016 · Jun 9, 2016 · Terminated
  Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe b