Disposable MRI Kit for 65/115 MR Injector System SSQK 65/115VS (UDI 00616258021607)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00616258021607), received between Oct 2, 2020 and Oct 25, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  BAYER MEDICAL CARE INC. WAS INFORMED THAT, WHILE PREPARING THE MEDRAD® SPECTRIS SOLARIS MR INJECTION SYSTEM FOR A PROCEDURE, THE DISPOSABLE SYRINGE BROKE. THIS RESULTED IN A PIECE OF THE SYRINGE, AS WELL AS THE CONTRAST MEDIA CONTAINED WITHIN THE SYRINGE, STRIKING THE MEDICAL ASSISTANT IN THE FACE AND EYE. THE USER'S EYE WAS FLUSHED WITH SALINE, AND THEY WERE SENT FOR EVALUATION AT AN URGENT CARE FACILITY. THE STAFF MEMBER HAS BEEN REPORTED AS DOING WELL FOLLOWING THIS EVALUATION.

  Patient problems: Eye Injury

  MAUDE report 18005449 ↗
• MalfunctionAug 25, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE SOLARIS MR DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE DISPOSABLE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365600 ↗
• MalfunctionAug 25, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE SOLARIS MR DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE DISPOSABLE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364775 ↗
• MalfunctionJun 23, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE SOLARIS MR DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE DISPOSABLE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050280 ↗
• MalfunctionOct 19, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A THIN, HAIR-LIKE FOREIGN BODY OF UNKNOWN ETIOLOGY WAS SEEN IN A SOLARIS MR SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY, OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10697814 ↗
• MalfunctionOct 2, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A THIN, HAIR-LIKE FOREIGN BODY OF UNKNOWN ORIGIN WAS SEEN IN THE MR SYRINGE. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10619436 ↗