MEDRAD® Stellant CT Injection System Stellant D-CE (REF SCT-310, SCT-321, SCT-322)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00616258008943), received between Dec 14, 2017 and Apr 2, 2026 — classified as 2 deaths, 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K072886, K082458, K082905); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A PATIENT WAS UNDERGOING AN ENHANCED CT SCAN WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE SUBSEQUENT IMAGES. THE PATIENT WAS PLACED ON HIGH FLOW OXYGEN VIA A NON-REBREATHER FACEMASK AND WAS PLACED ON THEIR LEFT SIDE IN TRENDELENBURG POSITION. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED THE FOLLOWING DAY WITHOUT FURTHER ISSUE.

  Patient problems: Air Embolism

  MAUDE report 24766355 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF THE FOLLOWING EVENT: A 47-YEAR-OLD PATIENT UNDERWENT A CT EXAMINATION OF THE ABDOMEN AND PELVIS WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). A 22-GAUGE INTRAVENOUS CATHETER WAS PLACED IN THE PATIENT'S LEFT WRIST, WHICH WAS NOTED TO BE A DIFFICULT INTRAVENOUS INSERTION. POST INJECTION, WHEN NO CONTRAST WAS OBSERVED IN THE ACQUIRED CT IMAGES, THE CUSTOMER REPORTED THAT APPROXIMATELY 100 ML OF FLUID EXTRAVASATED INTO THE PATIENT'S LEFT WRIST AREA. CONSEQUENTLY, THE PATIENT DEVELOPED COMPARTMENT SYNDROME AND LATER REQUIRED A SURGICAL FASCIOTOMY.

  Patient problems: Extravasation

  MAUDE report 24579027 ↗
• InjuryNov 27, 2024Electrostatic Discharge; Electrostatic Discharge

  THE CUSTOMER REPORTED THE FOLLOWING: DURING PREPARATION OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)), THE TECHNOLOGIST FELT A SHOCK IN HER HAND WHEN SHE TOUCHED THE EQUIPMENT. AS PER HOSPITAL PROTOCOL, THE EMPLOYEE WAS REFERRED TO THE EMERGENCY DEPARTMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797721 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE RECEIVED INFORMATION THAT A 73-YEAR-OLD MALE PATIENT WHO WAS UNDERGOING A CTA SCAN OF THE THORAX WITH CONTRAST SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM. THE CUSTOMER REPORTED THAT APPROXIMATELY 8-10 MLS OF ALLEGED AIR WAS VISUALIZED BY THE RADIOLOGIST IN THE PATIENT'S MAIN PULMONARY ARTERY WHILE REVIEWING THE IMAGES. THE PATIENT WAS PLACED IN TRENDELENBURG, LEFT LATERAL DECUBITUS POSITION, AND THEN ADMINISTERED HIGH FLOW OXYGEN. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR MONITORING. NO ADDITIONAL TREATMENT WAS REPORTED.

  Patient problems: Air Embolism

  MAUDE report 16121804 ↗
• DeathDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED THAT AN ALLEGED PATIENT DEATH OCCURRED 2-3 HOURS FOLLOWING A PROCEDURE IN WHICH A MEDRAD® STELLANT CT INJECTION SYSTEM WAS IN USE. THE CUSTOMER SITE REPORTED THE FOLLOWING INFORMATION: " THE PATIENT WITH A MEDICAL HISTORY OF AORTIC ANEURYSM UNDERWENT CONTRAST EXAMINATION FOR FEVER AND RESPIRATORY DISORDER. AS THE PATIENT FELT SICK, ANAPHYLACTIC SHOCK WAS SUSPECTED FIRST. SUBSEQUENTLY, THE PATIENT EXPERIENCED DECREASED BLOOD PRESSURE AND RESPIRATORY ARREST AND THEN DIED IN 2-3 HOURS. AFTER THE EXAMINATION OF THE CONDITION, IT WAS JUDGED THAT THE CAUSE OF THE DEATH WAS BLOOD AND CONTRAST MEDIUM INJECTED INTO THE LUNG. THE FACILITY REPORTED THAT THERE WAS NO MALFUNCTION OF THE STELLANT WITH CERTEGRA WORKSTATION USED AND THE CONTRAST MEDIUM INJECTED TO THE PATIENT WAS A NON-BAYER PRODUCT." MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, INCLUDING AN AUTOPSY REPORT, HAVE BEEN MADE; HOWEVER FURTHER DETAILS HAVE NOT BEEN PROVIDED TO DATE.

  Patient problems: Cardiac Arrest; Respiratory Arrest

  MAUDE report 15938905 ↗
• DeathApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO BAYER SERVICE. A (B)(6) FEMALE UNDERGOING A CT UROGRAM SUFFERED A MI (MYOCARDIAL INFARCTION) AND PASSED AWAY WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(4)). FOLLOWING THE CONTRAST INJECTION, THE PATIENT'S MEDICAL STATUS DECLINED. SHE SUFFERED RESPIRATORY DISTRESS AND SUBSEQUENT MI. THE EMERGENCY RESPONSE TEAM WAS CALLED AND LIFE SAVING MEASURES WERE INITIATED; HOWEVER THE PATIENT ULTIMATELY PASSED AWAY. THE CUSTOMER STATED THAT THE STAFF DO NOT ASSOCIATE THE USE OF THE INJECTOR TO BE INVOLVED WITH THE DEATH OF THE PATIENT. AN AUTOPSY STATEMENT HAS BEEN REQUESTED; HOWEVER ONE HAS NOT BEEN PROVIDED TO DATE.

  Patient problems: Cardiac Arrest; Respiratory Failure

  MAUDE report 14043035 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THE FOLLOWING: A (B)(6)-YEAR-OLD MALE PATIENT WITH AN ADMITTING DIAGNOSIS OF CHEST PAIN UNDERWENT A CARDIAC CT SCAN WITH INTRAVENOUS CONTRAST ENHANCEMENT WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM. ON THE FINAL CT IMAGES, SMALL AIR BUBBLES WERE OBSERVED IN THE PATIENT'S TRUNCUS PULMONALE, RIGHT ATRIUM AND RIGHT VENTRICLE. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC, HE WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION POST PROCEDURE. THE PATIENT WAS LATER DISCHARGED AND IS REPORTEDLY DOING WELL.

  Patient problems: Air Embolism

  MAUDE report 11237255 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THE FOLLOWING: A (B)(6)-YEAR-OLD MALE PATIENT WITH AN ADMITTING DIAGNOSIS OF ATYPICAL CHEST PAIN UNDERWENT A CARDIAC CT SCAN WITH INTRAVENOUS CONTRAST ENHANCEMENT WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM. ON THE FINAL CT IMAGES, A FEW SMALL AIR BUBBLES WERE OBSERVED IN THE PATIENT'S LEFT BRACHIOCEPHALIC VEIN, TRUNCUS PULMONALE, RIGHT ATRIUM AND RIGHT VENTRICLE. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC, HE WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION POST PROCEDURE. THE PATIENT WAS LATER DISCHARGED AND IS REPORTEDLY DOING WELL.

  Patient problems: Air Embolism

  MAUDE report 11236629 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THE FOLLOWING: A (B)(6)-YEAR-OLD MALE PATIENT WITH AN ADMITTING DIAGNOSIS OF ATYPICAL CHEST PAIN UNDERWENT A CARDIAC CT SCAN WITH INTRAVENOUS CONTRAST ENHANCEMENT WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM. ON THE FINAL CT IMAGES, A FEW SMALL AIR BUBBLES WERE VISUALIZED IN THE PATIENT'S TRUNCUS PULMONALE AND RIGHT VENTRICLE. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC, HE WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION POST PROCEDURE. THE PATIENT WAS LATER DISCHARGED AND IS REPORTEDLY DOING WELL.

  Patient problems: Air Embolism

  MAUDE report 11236061 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING REPORT WAS RECEIVED FROM A BAYER REPRESENTATIVE: ON (B)(6) 2021, THE SITE REPORTED TO A BAYER REPRESENTATIVE THAT A PATIENT HAD SUFFERED AN EXTRAVASATION A FEW MONTHS AGO WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION. THE PATIENT WAS REPORTED TO REQUIRE SURGICAL INTERVENTION POST INCIDENT. THE CUSTOMER'S RISK MANAGEMENT REPRESENTATIVE STATED THAT THERE WAS NO ISSUE IDENTIFIED WITH THE MEDRAD® STELLANT CT INJECTION SYSTEM DURING THEIR INTERNAL INVESTIGATION. IN ADDITION, THE INJECTOR SYSTEM HAS BEEN IN USE DAILY SINCE THE OCCURRENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS FROM THE CUSTOMER WITHOUT RESPONSE AT THIS TIME.

  Patient problems: Infiltration into Tissue

  MAUDE report 11230409 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAYER REPRESENTATIVE REPORTED THE FOLLOWING: A CUSTOMER REPORTED THAT A PATIENT SUFFERED A CONTRAST REACTION WHILE CONNECTED TO THE STELLANT INJECTOR SYSTEM. THE PATIENT WAS PLACED ON A VENTILATOR AND ADMITTED TO THE INTENSIVE CARE UNIT FOR TWO DAYS POST EVENT. THE CUSTOMER REQUESTED AN INJECTOR CHECKOUT; HOWEVER, THE CUSTOMER STATED THEY DID NOT FEEL THE INJECTOR WAS ASSOCIATED WITH THE PATIENT EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT RESPONSE FROM THE CUSTOMER.

  Patient problems: Hypersensitivity/Allergic reaction; Ventilator Dependent

  MAUDE report 11018878 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAYER REPRESENTATIVE REPORTED THE FOLLOWING: A (B)(6)-YEAR-OLD, FEMALE EMERGENCY ROOM PATIENT WHO REPORTEDLY FELL DOWN A FLIGHT OF STAIRS WAS UNDERGOING MULTIPLE CT SCANS OF THE BODY WITH AND WITHOUT CONTRAST MEDIA UTILIZING A STELLANT INJECTOR TO RULE OUT INJURY POST FALL. AN INDETERMINATE AMOUNT OF WAS OBSERVED IN THE RIGHT ATRIUM, MAIN PULMONARY ARTERY, AND BRACHIOCEPHALIC VEIN. THE PATIENT WAS PLACED IN TRENDELENBURG POSITION FOR 24 HOURS AND ADMITTED AS AN INPATIENT. THE PATIENT IS REPORTED TO BE RECOVERING AND IS EXPECTED TO BE DISCHARGED FROM THE HOSPITAL SOON.

  Patient problems: Air Embolism

  MAUDE report 10677425 ↗
• MalfunctionMay 29, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLLOWING: AS THE TECHNOLOGIST WAS MANEUVERING THE INJECTOR INTO POSITION FOR A PATIENT EXAM, THE INJECTOR HEAD DISENGAGED FROM THE MOUNTING STRUCTURE. THE INJECTOR HEAD WAS CAUGHT BY THE TECHNOLOGIST WHICH PREVENTED IT FROM FALLING TO THE FLOOR. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10100484 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF AN EXTRAVASATION THAT OCCURRED DURING AN ENHANCED CT SCAN WHILE A PATIENT WAS CONNECTED TO A STELLANT CT INJECTION SYSTEM. THE CUSTOMER REPORTED THAT APPROXIMATELY 220ML OF FLUID EXTRAVASATED (120 ML CONTRAST AND 100ML SALINE) AN ICEPACK WAS APPLIED TO THE AFFECTED EXTREMITY AND THE PATIENT WAS RE-EVALUATED THE FOLLOWING DAY BY A SURGEON WHO DETERMINED THAT THEY SHOULD CONTINUE TO APPLY ICE AS NEEDED. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: Extravasation

  MAUDE report 9739549 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED THE FOLLOWING: A (B)(6) YEAR OLD FEMALE PATIENT WAS UNDERGOING A CT OF THE CHEST FOR A SUSPECTED PULMONARY EMBOLUS AND WAS INJECTED WITH CONTRAST MEDIA USING A STELLANT INJECTOR. THE PATIENT HAD A POSITIVE D-DIMER TEST AND HAD EXPERIENCED CHEST PAIN PRIOR TO ARRIVING IN CT. THE RADIOLOGIST INTERPRETING THE STUDY VISUALIZED A LARGE AMOUNT OF AIR IN THE RIGHT SUBCLAVIAN VEIN, SVC, RIGHT ATRIUM AND RIGHT VENTRICLE. THE PATIENT EXPERIENCED NO SYMPTOMS; HOWEVER, SHE WAS PROACTIVELY PLACED IN THE TRENDELENBURG POSITION. THE FOLLOWING DAY, A CT OF THE CHEST WITHOUT CONTRAST WAS PERFORMED. THE RADIOLOGIST REVIEWED THE IMAGES AND FOUND COMPLETE RESOLUTION OF THE PREVIOUSLY NOTED AIR. THE PATIENT WAS DISCHARGED TO HOME IN GOOD CONDITION.

  Patient problems: Air Embolism; Embolism

  MAUDE report 8524235 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLLOWING: THE STELLANT D INJECTOR (SERIAL NUMBER (B)(4)) DISENGAGED FROM THE MOUNTING STRUCTURE AND WAS CAUGHT BY THE TECHNOLOGIST PREVENTING IT FROM FALLING TO THE FLOOR. NO INJURY OR ADVERSE EVENT WAS REPORTED. 3PS.

  Patient problems: No Patient Involvement

  MAUDE report 8085110 ↗
• MalfunctionJul 23, 2018Smoking; Defective Device; Electrical Overstress; Environmental Particulates; Smoking; Defective Device; Electrical Overstress; Environmental Particulates

  A BAYER REPRESENTATIVE HAD REPORTED SEEING SMOKE COMING OUT OF THE STELLANT CT INJECTOR BASE UNIT. THE INJECTOR WAS POWERED DOWN AND UNPLUGGED FROM THE WALL. NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7710244 ↗
• InjuryMar 6, 2018Use of Device Problem

  WE RECEIVED THE FOLLOWING INFORMATION FROM THE CUSTOMER: A (B)(6) YEAR OLD PATIENT UNDERWENT A CT SCAN FOR PULMONARY EMBOLISM SUFFERED AN EXTRAVASATION OF 30 CC'S OF CONTRAST TO THE LEFT FOREARM WHILE ATTACHED TO A STELLANT INJECTOR SYSTEM. THE PATIENT REQUIRED SURGICAL DEBRIDEMENT OF THE WOUND. THE CUSTOMER REPORTED THAT THE PATIENT RECEIVED A FOLLOW UP EVALUATION AND IS REPORTED TO BE DOING WELL.

  Patient problems: Extravasation; Pulmonary Embolism

  MAUDE report 7318819 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A (B)(6) YEAR OLD FEMALE WITH A HISTORY OF A PERIUMBILICAL ABSCESS UNDERWENT A CT OF THE ABDOMEN AND PELVIS WITH CONTRAST WHILE CONNECTED TO A STELLANT INJECTOR (SERIAL NUMBER (B)(4)). POST INJECTION, THE RADIOLOGIST VISUALIZED AN INDETERMINATE AMOUNT OF AIR IN THE RIGHT VENTRICLE ON THE IMAGES. NO UNUSUAL (TECHNICAL) ISSUES WERE REPORTED DURING THE PROCEDURE TO EXPLAIN THE PRESENCE OF AIR. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS KEPT FOR 24 HOUR OBSERVATION AND DISCHARGED TO HOME THE NEXT DAY.

  Patient problems: Air Embolism; Patient Problem/Medical Problem

  MAUDE report 7227628 ↗
• InjuryDec 14, 2017Use of Device Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A PATIENT SUFFERED AN EXTRAVASATION WHILE CONNECTED TO THE STELLANT W/CERTEGRA INJECTOR SYSTEM DURING A CT ABDOMEN/PELVIS EXAMINATION WITH CONTRAST TO EVALUATE RIGHT UPPER QUADRANT PAIN. POST PROCEDURE, A SMALL AMOUNT OF SWELLING WAS EVIDENT IN THE LEFT ANTECUBITAL AREA. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN UNRELATED INFECTION AND PER SITE PROTOCOL RECEIVED A SKIN EVALUATION PERFORMED BY WOUND CARE. NO ADDITIONAL TREATMENT REGARDING THE EXTRAVASATION WAS REPORTED.

  Patient problems: Extravasation

  MAUDE report 7117494 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072886, K082458, K082905. One submission often covers many models, so check the product and lot details in each record.

• Z-2768-2016 · Aug 2, 2016 · Terminated
  Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended
• Z-1686-2015 · Sep 20, 2013 · Terminated
  MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in co