MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-QFT (UDI 00616258005171)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00616258005171), received between Jan 11, 2017 and Aug 24, 2017 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2017Product Quality Problem; Product Quality Problem

  THE SITE REPORTED THE FOLLOWING: A FOREIGN BODY THAT "LOOKS LIKE A GNAT" WAS VISUALIZED IN THE LOW PRESSURE CONNECTING TUBING SET (LPCT). THIS WAS OBSERVED PRIOR TO USE AND THE TUBING WAS NEVER USED ON A PATIENT.

  Patient problems: Not Applicable

  MAUDE report 6817755 ↗
• MalfunctionAug 18, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT 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 Known Impact Or Consequence To Patient

  MAUDE report 6803395 ↗
• MalfunctionJan 12, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY NOTICED THE PRESENCE OF FINE WHITE PARTICLES AROUND THE SYRINGE AS WELL AS THE QUICK FILL TUBE (QFT). THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED. NOTE: REFERENCE THE FOLLOWING REPORT NUMBERS FOR RELATED REPORTS: 2520313-2017-00003. 2520313-2017-00005.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6245457 ↗
• MalfunctionJan 12, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY NOTICED THE PRESENCE OF FINE WHITE PARTICLES AROUND THE SYRINGE AS WELL AS THE QUICK FILL TUBE (QFT). THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED. NOTE: REFERENCE THE FOLLOWING REPORT NUMBERS FOR RELATED REPORTS: 2520313-2017-00003. 2520313-2017-00004.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6245367 ↗
• MalfunctionJan 12, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY NOTICED THE PRESENCE OF FINE WHITE PARTICLES AROUND THE SYRINGE AS WELL AS THE QUICK FILL TUBE (QFT). THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED. NOTE: REFERENCE THE FOLLOWING REPORT NUMBERS FOR RELATED REPORTS: 2520313-2017-00003 AND 2520313-2017-00005.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6245289 ↗
• MalfunctionJan 11, 2017Product Quality Problem; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY NOTICED THE PRESENCE OF FINE WHITE PARTICLES AROUND THE SYRINGE AS WELL AS THE QUICK FILL TUBE (QFT). 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 6243341 ↗

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