MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-SPK (UDI 00616258005218)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00616258005218), received between Jul 12, 2017 and Mar 12, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9824178 ↗
• MalfunctionAug 9, 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. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: Not Applicable

  MAUDE report 8878893 ↗
• MalfunctionFeb 26, 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 8370624 ↗
• MalfunctionOct 31, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT THE CUSTOMER OBSERVED A BLACK PARTICULATE 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 8023550 ↗
• MalfunctionOct 24, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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: Not Applicable

  MAUDE report 8000425 ↗
• MalfunctionAug 3, 2018Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLENT 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 Patient Involvement

  MAUDE report 7747557 ↗
• MalfunctionJul 19, 2018Product Quality Problem; Defective Component; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  THE SITE REPORTED THE FOLLOWING: A FOREIGN BODY WAS FOUND INSIDE THE LOW PRESSURE CONNECTOR TUBING (LPCT) OF A SSS-CTP-SPK SYRINGE KIT. THE KIT WAS REMOVED FROM THE AREA AND WAS NOT USED FOR A PATIENT.

  Patient problems: Not Applicable

  MAUDE report 7704627 ↗
• MalfunctionMay 14, 2018Clumping in Device or Device Ingredient; Sediment, Precipitate Or Deposit In Device Or Device Ingredient; Clumping in Device or Device Ingredient; Sediment, Precipitate Or Deposit In Device Or Device Ingredient

  THE SITE REPORTED THE FOLLOWING: A STELLANT DISPOSABLE SET HAS VISIBLE FOREIGN MATERIAL IN THE TUBING. THIS IS A SSS-CPT-SPK SYRINGE KIT. THE KIT WAS REMOVED FROM THE AREA AND WAS NOT USED FOR A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7510600 ↗
• MalfunctionJan 31, 2018Particulates

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT THE CUSTOMER OBSERVED A BLACK PARTICULATE INSIDE THE TUBING. 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 7230619 ↗
• MalfunctionJul 12, 2017Particulates

  THE SITE REPORTED THE FOLLOWING: A RADIOLOGIC TECHNOLOGIST REMOVED A SYRINGE FROM THE SYRINGE KIT PACKAGING, SPIKED A BOTTLE OF CONTRAST MEDIA AND BEGAN TO FILL THE SYRINGE WITH CONTRAST MEDIA. ABOUT 2/3 OF THE CONTRAST WAS INTO THE SYRINGE WHEN HE NOTED 1 OR 2 BLACK FLECKS FLOATING IN THE CONTRAST. HE STOPPED FILLING THE SYRINGE AND TOOK A PHOTO OF THE BLACK FLECK. HE THEN REMOVED THE SYRINGE AND DISCARDED IT. THE SYRINGE WAS NEVER USED FOR A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6706430 ↗
• MalfunctionJul 12, 2017Air Leak

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW BUBBLES OF WATER 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 6705813 ↗

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