MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPK (UDI 00616258005188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00616258005188), received between Apr 11, 2017 and Oct 24, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2019Manufacturing, Packaging or Shipping 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: No Patient Involvement

  MAUDE report 9235346 ↗
• MalfunctionOct 22, 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. NOTE: ON OCTOBER 17, 2019, WE RECEIVED A COPY OF MEDWATCH (MW5090081).

  Patient problems: No Patient Involvement

  MAUDE report 9218432 ↗
• MalfunctionOct 11, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT THE CUSTOMER OBSERVED A FOREIGN MATERIAL UNDER THE BLUE DUST CAP ON THE SPIKE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: Not Applicable

  MAUDE report 9180011 ↗
• MalfunctionJul 3, 2018Bent; Loose or Intermittent Connection

  THE TUBING FOR THE MEDRAD INJECTOR SYRINGE WOULD NOT SCREW DOWN ONTO THE INJECTOR HEAD FOR CONTRAST INJECTION. UPON LOOKING AT THE INJECTOR SYRINGE TIP, IT WAS NOTICED THAT THE TIP WAS BENT AND FLEXIBLE WHICH PREVENTS THE TUBING TO PROPERLY CONNECT FOR INJECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658478 ↗
• MalfunctionMar 14, 2018Product Quality Problem; Product Quality Problem

  THE SITE REPORTED THE FOLLOWING: A FOREIGN PARTICLE WAS DETECTED INSIDE OF THE CT SYRINGE. THE PARTICLE APPEARED TO BE BLACK PLASTIC ON THE TIP OF THE PLUNGER.

  Patient problems: No Information

  MAUDE report 7339351 ↗
• MalfunctionJan 2, 2018Product Quality Problem; Product Quality Problem

  THE SITE REPORTED THE FOLLOWING: A STELLANT SDS-CTP-SPK SYRINGE WAS FILLED WITH CONTRAST MEDIA USING A SPIKE INTO THE CONTRAST MEDIA VIAL AND A WHITE, PLASTIC-LIKE PARTICLE WAS NOTED TO BE FLOATING IN THE CONTRAST INSIDE THE SYRINGE. THE KIT WAS REMOVED FROM THE AREA AND WAS NOT USED FOR A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7156864 ↗
• MalfunctionDec 19, 2017Failure to Disconnect

  WHEN DRAWING UP IV CONTRAST, THE SPIKE WOULD NOT DETACH FROM THE SYRINGE CAUSING IT TO MALFUNCTION. MANUFACTURER RESPONSE: FOR STERILE DISPOSABLE SYRINGE, MEDRAD (PER SITE REPORTER) WILL REVIEW AND RESPOND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7128021 ↗
• MalfunctionOct 10, 2017Break; Fluid/Blood Leak

  WHEN STARTING IV CONTRAST INJECTION FROM THE POWER INJECTOR, TUBING ARISING OFF OF THE SYRINGE HAD A BREAK IN THE TUBING AND CONTRAST SPRAYED ALL OVER THE TECHNOLOGIST, MACHINE, AND THE FLOOR. THE SCAN WAS PAUSED AND IV CONTRAST WAS RELOADED WITH NEW SYRINGE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935447 ↗
• MalfunctionSep 27, 2017Product Quality Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  THE SITE REPORTED THE FOLLOWING: A STELLANT DISPOSABLE SET HAS VISIBLE DEBRIS IN THE LINE. THIS IS A SDS-CTP-SPK SYRINGE KIT. THE KIT WAS REMOVED FROM THE AREA AND WAS NOT USED FOR A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896838 ↗
• MalfunctionSep 20, 2017Product Quality Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem

  THE SITE REPORTED THE FOLLOWING: A TECHNOLOGIST PLACED THE SYRINGES FROM AN SDS-CTP-SPK KIT (LOT NUMBER 8533438) ON THE INJECTOR AND PRIOR TO FILLING THE SYRINGES HE NOTICED A PIECE OF PLASTIC INSIDE ONE OF THE SYRINGE BARRELS. THE SYRINGES WERE IMMEDIATELY REMOVED AND NOT USED FOR A PATIENT.

  Patient problems: No Code Available

  MAUDE report 6879250 ↗
• MalfunctionAug 22, 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 6809762 ↗
• MalfunctionApr 11, 2017Particulates

  THE FOLLOWING INFORMATION WAS OBTAINED FROM THE CUSTOMER: THE CUSTOMER REPORTED OBSERVING A WHITE PAPER LIKE PARTICULATE INSIDE THE CT SYRINGE BARREL UPON OPENING THE SYRINGE KIT BEFORE USE ON A PATIENT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6479720 ↗

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