MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPK (UDI 00616258007939)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00616258007939), received between Jun 28, 2017 and May 4, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770842 ↗
• MalfunctionMar 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9852888 ↗
• MalfunctionJun 17, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE SITE REPORTED THE FOLLOWING: THE TECHNICIAN STATED THAT A HAIR WAS OBSERVED IN THE SYRINGE BARREL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Not Applicable

  MAUDE report 8703342 ↗
• MalfunctionJun 10, 2019Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  THE SITE REPORTED THE FOLLOWING: THE TECHNICIAN STATED THAT SHE OBSERVED A FILIFORM FOREIGN BODY INSIDE THE SYRINGE DURING THE SALINE INFUSION PROCESS. THERE WAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8683070 ↗
• MalfunctionOct 24, 2018Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  THE SITE REPORTED THE FOLLOWING: A NURSE REPORTED THAT A WHITE FOREIGN PARTICLE WAS FOUND INSIDE ONE OF THE SYRINGES IN A SDS-CTP-SPK KIT. THE KIT WAS NOT USED FOR A PATIENT AND WAS REMOVED FROM THE AREA TO BE RETURNED FOR INVESTIGATION.

  Patient problems: Not Applicable

  MAUDE report 7999447 ↗
• MalfunctionApr 17, 2018Product Quality Problem; Device Contamination with Chemical or Other Material; Product Quality Problem; Device Contamination with Chemical or Other Material

  THE SITE REPORTED THE FOLLOWING: AFTER FILLING THE CT DISPOSABLE SYRINGE WITH SALINE, THE TECHNOLOGIST NOTICED A THIN, HAIR-LIKE FOREIGN BODY WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7436802 ↗
• MalfunctionDec 19, 2017Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY OBSERVED A WHITE PARTICULATE INSIDE 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 7128231 ↗
• MalfunctionJun 28, 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 ON ONE OF THE FILLING SPIKES. THE CUSTOMER ELECTED NOT TO USE THE SPIKE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6673135 ↗

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