MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00616258005256), received between Dec 11, 2017 and Dec 4, 2019 — classified as 5 malfunctions.

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

6 other recalls cover devices cleared under the same FDA submission (K023183); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT THE CUSTOMER OBSERVED A FOREIGN MATERIAL ON THE SPIKE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement; Not Applicable

  MAUDE report 9412789 ↗
• MalfunctionJan 14, 2019Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT THE CUSTOMER OBSERVED A FOREIGN BODY INSIDE THE TUBING. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: Not Applicable

  MAUDE report 8243962 ↗
• MalfunctionMay 2, 2018Detachment Of Device Component; Component Falling

  T-CONNECTOR (FROM STERILE DISPOSABLE SYRINGE KIT) FELL OFF IN TECHNOLOGIST'S HAND WHEN ATTEMPTING TO CONNECT TUBING TO POWER INJECTOR.

  Patient problems: No Information

  MAUDE report 7482460 ↗
• MalfunctionMar 12, 2018Device Issue; Device Issue

  THE SITE REPORTED THE FOLLOWING: A STELLANT SDS-CTP-SCS SYRINGE WAS FILLED WITH CONTRAST MEDIUM USING A SPIKE INTO THE CONTRAST MEDIUM VIAL AND AFTER FILLING A HAIR-LIKE FOREIGN PARTICLE WAS NOTED TO BE FLOATING IN THE CONTRAST INSIDE THE SYRINGE. THE SYRINGE KIT WAS REMOVED FROM THE AREA AND WAS NOT USED FOR A PATIENT.

  Patient problems: No Information

  MAUDE report 7330736 ↗
• MalfunctionDec 11, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY OBSERVED YELLOW DEBRIS WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103725 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023183. 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
• Z-0147-2012 · Oct 24, 2011 · Terminated
  Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous
• Z-1954-2010 · May 24, 2010 · Terminated
  Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
• Z-0154-06 · Oct 10, 2005 · Terminated
  Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
• Z-0257-05 · Nov 3, 2004 · Terminated
  Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
• Z-0039-05 · Oct 8, 2004 · Terminated
  Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT