MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPK (UDI 00616258022833)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00616258022833), received between Aug 24, 2022 and Mar 12, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

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

• MalfunctionMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED CONNECTION AND LEAKING ISSUES WHILE USING A MEDRAD® STELLANT FLEX DISPOSABLE SYRINGE KIT (FLEXD-150-SPK, LOT NUMBER 8659907). THE CONTRAST HAD LEAKED ONTO THE FLOOR UPON WHICH THE TECHNOLOGIST SUBSEQUENTLY SLIPPED AND FELL. AFTER BEING EVALUATED IN THE EMERGENCY ROOM, THE EMPLOYEE WAS RELEASED BACK TO WORK WITH NO ISSUES REPORTED.

  Patient problems: Back pain

  MAUDE report 21582422 ↗
• MalfunctionApr 16, 2024

  MEDRAD STELLANT FLEX TUBING CRACKING/LEAKING. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127762 ↗
• MalfunctionJan 25, 2024

  MEDRAD SYRINGE NOTED TO HAVE FLOATING SCRAP OF PLASTIC MATERIAL INSIDE ONE OF THE TWO SYRINGES.

  Patient problems: Insufficient Information

  MAUDE report 18578886 ↗
• MalfunctionMay 25, 2023Leak/Splash; Defective Device; Incomplete or Inadequate Connection

  AT (B)(6) HOSPITAL, ON (B)(6) 2023 IN CT, CONTRAST SPRAYED OUT OF THE SYRINGE CONNECTION TUBING DURING A PATIENT INJECTION. THE CONTRAST CAME OUT OF A FIXED MANUFACTURER CONNECTION POINT, NOT FROM A CONNECTION POINT THAT THE STAFF CONNECTS MANUALLY. THE IS POTENTIALLY DANGEROUS BECAUSE IT COULD INTRODUCE AIR INTO THE PATIENT. IT COULD ALSO SPRAY CONTRAST INTO THE EYES OF A PATIENT. SYRINGE REF # FLEXD-150-SPK, LOT # 8624657, EXP DATE 2026-09-30.

  Patient problems: Chemical Exposure

  MAUDE report 17011216 ↗
• MalfunctionFeb 16, 2023Break

  MEDRAD STELLANT FLEX SYRINGE OPENED FOR USE ON INJECTOR TUBING IN THE KIT WAS BROKEN AT THE SYRINGE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398912 ↗
• MalfunctionDec 6, 2022Material Puncture/Hole

  HOLE IN TUBING; 150ML STERILE DISPOSABLE SYRINGE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15932900 ↗
• MalfunctionAug 24, 2022Material Puncture/Hole

  I PRIMED THE TUBING AGAIN AFTER IT WAS DISCONNECTED FROM THE PATIENT TO FIND A HOLE IN THE TUBING. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15293180 ↗

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