MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPK (UDI 00616258022901)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258022901), received between Jun 23, 2021 and Jun 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Entrapment of Device; Connection Problem

  UPON LOADING FOR CONTRAST ON THE MEDRAD STELLANT INJECTOR, CT TECH OPENED A NEW AND SEALED DUAL SYRINGE KIT TO LOAD CONTRAST AND SALINE. SYRINGES WERE PLACED ON INJECTOR. TECH HAD DIFFICULTY TRYING TO ATTACH ENCLOSED SPIKE TO TIP OF SYRINGE. UPON CLOSER INSPECTION, TECH NOTICED A SMALL PLASTIC PIECE IN THE MALE LUER LOCK WELL OF THE THREADED SECTION OF THE TIP. THE SYRINGE WAS REMOVED FROM INJECTOR, PLASTIC PIECE WAS REMOVED FROM THE WELL AND NOT USED. NO PATIENT HARM. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12057962 ↗

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