MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPK (UDI 00616258007045)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00616258007045), received between Aug 6, 2018 and Jun 19, 2019 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 Patient Involvement

  MAUDE report 8713271 ↗
• MalfunctionFeb 8, 2019Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem

  THE SITE REPORTED THE FOLLOWING: A RADIOLOGY TECHNOLOGIST REPORTED THAT UPON OPENING 3 SDS-CTP-SPK SYRINGE KITS FROM THE SAME BOX, A WHITE POWDER WAS OBSERVED ON THE SYRINGES. THE KITS WERE NOT USED FOR A PATIENT AND WERE REMOVED FROM THE AREA, BEING SAVED TO BE RETURNED FOR INVESTIGATION.

  Patient problems: Not Applicable

  MAUDE report 8321875 ↗
• MalfunctionJan 24, 2019Leak/Splash

  THE CT DEPARTMENT IS EXPERIENCING LEAKING AT THE SPIKE AIR VENT WHEN THEY ARE LOADING THE IV CONTRAST AND SALINE ON THE MEDRAD STELLANT STERILE DISPOSABLE SYRINGE SPIKES. IT LEAKS AT THE SMALL ROUND WHITE AIR VENT. THIS HAS OCCURRED IN APPROXIMATELY 20 AIR VENTS, ALL WITH THE LOT# OF 8556158. THERE HAS BEEN NO PATIENT IMPACT. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, MEDRAD STELLANT STERILE DISPOSABLE SYRINGE (PER SITE REPORTER) BAYER IS INVESTIGATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273152 ↗
• MalfunctionNov 30, 2018Break

  UPON OPENING THE SYRINGE PACKAGE AND PULLING ONE SYRINGE OUT, TECH NOTICED THAT THE PLASTIC REMOVABLE CAP WAS BROKE AND COULD NOT BE REMOVED. PACKAGE WAS REMOVED FROM SERVICE AND NEW PACKAGE OPENED. MANUFACTURER RESPONSE FOR STERILE DISPOSABLE SYRINGE, MEDRAD STELLANT STERILE DISPOSABLE SYRINGE (PER SITE REPORTER). NO RESPONSE YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8119613 ↗
• MalfunctionAug 29, 2018Product Quality Problem; Defective Device; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Defective Device; Manufacturing, Packaging or Shipping Problem

  THE SITE REPORTED THE FOLLOWING: WHITE PARTICLES WERE SEEN IN THE SYRINGE BARREL OF A SDS-CTP-SPK SYRINGE KIT. THE KIT WAS REMOVED FROM THE AREA AND WAS NOT USED FOR A PATIENT.

  Patient problems: Not Applicable

  MAUDE report 7828239 ↗
• MalfunctionAug 6, 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 STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE COVER OF THE SPIKE. THE CUSTOMER ELECTED NOT TO USE THE DISPOSABLE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7752278 ↗

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