MEDRAD® Stellant Sterile Disposable Syringe FLEXD-150-SPKRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258010663), received between Apr 10, 2020 and Apr 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K173773); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2020Break

  ELDERLY FEMALE WITH HISTORY OF TYPE 2 DIABETES, HYPERTENSION AND CONGESTIVE HEART FAILURE. PATIENT WAS HAVING A CT ANGIO OF CHEST, "INJECTOR WAS SET TO INJECT A PATIENT AT 5CC/SEC WITH A TOTAL OF 94CC, THE SALINE FLUSH WORKED FINE, THEN WHEN THE CONTRAST STARTED ONLY 1 CC WAS INJECTED AND THEN THE SYRINGE BROKE AT THE BOTTOM. THE INJECTOR WAS RELOADED AND PATIENT'S EXAM WAS THEN FINISHED WITHOUT FURTHER INCIDENT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9948502 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173773. One submission often covers many models, so check the product and lot details in each record.

• Z-0745-2019 · Dec 14, 2018 · Terminated
  MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Inje