MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00616258022888), received between Oct 30, 2020 and Nov 4, 2021 — classified as 3 malfunctions.

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

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 5, 2020Terminated

   Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

   Z-0483-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT FLEX CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE LOW PRESSURE CONNECTOR TUBING (LPCT). THE CUSTOMER ELECTED NOT TO USE THE TUBING. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752547 ↗
• MalfunctionOct 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A FOREIGN MATERIAL WAS OBSERVED IN A STELLANT FLEX SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697905 ↗
• MalfunctionOct 30, 2020Leak/Splash

  MEDRAD STELLANT FLEX SYRINGES ARE CONSTANTLY LEAKING CONTRAST WHEN IN USE. CONTACTED (B)(4) AND STATED LOT 8586385 HAS KNOWN ISSUES, AND ALL SUPPLY SHOULD BE PULLED FROM BEING USED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10770196 ↗

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