MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPK (UDI 00616258022130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00616258022130), received between Mar 23, 2020 and Apr 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionApr 30, 2021Break

  MEDRAD SYRINGE FOR CONTRAST POWER INJECTOR BROKE DURING POWER INJECTION. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759809 ↗
• MalfunctionFeb 18, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW AN UNKNOWN PARTICULATE WITHIN THE MALE LUER CONNECTOR OF 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 11343696 ↗
• MalfunctionMar 23, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN PARTICLE 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 9868353 ↗

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