MEDRAD Stellant CT Injection SystemRecalls & reported problems across all models

We found 2 models of MEDRAD Stellant CT Injection System by Bayer Medical Care Inc. in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2017 and Apr 2, 2026 — classified as 4 deaths, 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MEDRAD Stellant CT Injection System problems

MEDRAD Stellant CT Injection System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MEDRAD® Stellant CT Injection System Stellant D-CE

  Injector And Syringe, Angiographic
  2 deaths20 reports
• MEDRAD® Stellant CT Injection System Stellant D-CE

  Injector And Syringe, Angiographic
  2 deaths16 reports

Recent MEDRAD Stellant CT Injection System adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BAYER MEDICAL CARE WAS NOTIFIED OF THE FOLLOWING EVENT: AN (B)(6) FEMALE EMERGENCY DEPARTMENT PATIENT UNDERWENT A CT EXAMINATION TO EVALUATE AN ANEURYSM CLIP WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTOR (SERIAL NUMBER (B)(6)). CONTRAST MEDIA WAS ADMINISTERED WITHOUT INCIDENT. AFTER THE CT EXAM, THE PATIENT WAS TRANSPORTED BACK TO THE EMERGENCY DEPARTMENT AND EXHIBITED NO SYMPTOMS. AIR BUBBLES WERE NOTED ON THE ACQUIRED CT IMAGES. FURTHER CLINICAL EVALUATION LATER IDENTIFIED A PULMONARY EMBOLISM. A NON CONTRAST FOLLOW UP CT STUDY WAS SUBSEQUENTLY REQUESTED AND COMPLETED. ON MARCH 6, 2026, THE CUSTOMER PROVIDED BAYER WITH ADDITIONAL INFORMATION REGARDING THE INCIDENT, INDICATING THAT SUBSEQUENT CLINICAL EVALUATIONS REVEALED AIR EMBOLI, INCLUDING A 30 × 13 MM COLLECTION IN THE PULMONARY TRUNK AND A 9 × 16 MM COLLECTION IN THE RIGHT VENTRICLE. THE PATIENT'S CURRENT STATUS IS NOTED AS GOOD.

  Patient problems: Air Embolism

  MAUDE report 24400418 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE BECAME AWARE OF AN ALLEGED AIR INJECTION THAT OCCURRED DURING A CT EXAMINATION OF THE CHEST WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE ADMINISTRATION OF 20 ML OF SALINE AT A PROGRAMMED FLOW RATE OF 3 ML/SECOND, INTRAVASCULAR AIR WAS IDENTIFIED ON THE ACQUIRED CT IMAGES IN THE LEFT INNOMINATE VEIN. A SUBSEQUENT NON-CONTRAST SCAN WAS PRESCRIBED AND DEMONSTRATED REABSORPTION OF THE AIR. THE PATIENT WAS MONITORED ON SITE AND REMAINED CLINICALLY STABLE, WITH NO REPORTED SYMPTOMS.

  Patient problems: Air Embolism

  MAUDE report 24388904 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN 85-YEAR-OLD FEMALE PATIENT IN THE EMERGENCY DEPARTMENT UNDERWENT A CONTRAST-ENHANCED CT SCAN OF THE THORAX FOR EVALUATION OF A SUSPECTED PULMONARY EMBOLISM. THE PROCEDURE WAS PERFORMED USING A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING COMPLETION OF THE CONTRAST INJECTION, AN UNDETERMINED AMOUNT OF AIR WAS VISUALIZED WITHIN THE PATIENT'S PULMONARY ARTERIES AND LEFT VENTRICLE ON THE ACQUIRED CT IMAGES. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION AND MONITORING. ACCORDING TO THE CUSTOMER, THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SYMPTOMS, AND IT WAS LATER CONFIRMED THAT NO ADVERSE HEALTH CONSEQUENCES RESULTED FROM THE EVENT.

  Patient problems: Air Embolism

  MAUDE report 24223186 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: (B)(6) YEAR OLD FEMALE PATIENT UNDERGOING A CONTRAST ENHANCED CT SCAN OF THE THORAX WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, APPROXIMATELY 9ML OF AIR WAS VISUALIZED WITHIN THE PATIENT'S NECK ON THE DISPLAYED IMAGES. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT AND SUBSEQUENTLY UNDERWENT A PERCUTANEOUS INTRAVASCULAR ULTRASOUND GUIDED ASPIRATION OF THE VENOUS AIR. ONCE COMPLETED, THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Air Embolism

  MAUDE report 23827951 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A PATIENT WAS UNDERGOING AN ENHANCED CT SCAN OF THE ABDOMEN WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). DURING THE EXAMINATION, THE TECHNOLOGIST NOTED THAT THERE WAS NO CONTRAST ON THE IMAGES DISPLAYED. THE PATIENT WAS EVALUATED AND FOUND THAT APPROXIMATELY 100ML OF CONTRAST HAD EXTRAVASATED AT THE LEFT ANTECUBITAL INJECTION SITE. A COLD COMPRESS WAS APPLIED TO THE AFFECTED LIMB, AND THE PATIENT WAS REFERRED TO A PLASTIC SURGEON FOR CONSULTATION. THE PATIENT WAS REPORTED TO HAVE RECOVERED AFTER THE CONSULTATION; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Extravasation

  MAUDE report 23696916 ↗
• InjuryMay 29, 2025Adverse 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 MEDRAD® STELLANT CT INJECTION SYSTEM, SERIAL NUMBER (B)(6). DURING THE INJECTION, THE PATIENT COMPLAINED OF PAIN, SWELLING AND TIGHTNESS IN THEIR ARM. THE CUSTOMER REPORTED THAT APPROXIMATELY 30ML OF SALINE AND CONTRAST HAD EXTRAVASATED AT THE PATIENT'S LEFT ANTECUBITAL INJECTION SITE TO WHICH A COLD COMPRESS WAS APPLIED. IN ADDITION, THE ATTENDING PHYSICIAN PRESCRIBED THE APPLICATION OF MAGNESIUM SULPHATE AND DEXAMETHASONE TO THE INJECTION SITE. THE PATIENT IS REPORTED TO BE DOING WELL WITH NO OTHER ISSUES REPORTED.

  Patient problems: Extravasation

  MAUDE report 22105193 ↗
• DeathFeb 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AN ALLEGED AIR INJECTION AND SUBSEQUENT PATIENT DEATH OCCURRED WHILE A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)) WAS IN USE. A REQUEST FOR ADDITIONAL INFORMATION, INCLUDING AN AUTOPSY REPORT AND/OR CAUSE OF DEATH REPORT, HAS BEEN MADE. HOWEVER, THE HOSPITAL INDICATED THAT A POLICE INVESTIGATION WAS UNDERWAY AND THEREFORE, LIMITED INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Air Embolism

  MAUDE report 21297498 ↗
• 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 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 74-YEAR-OLD FEMALE SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT A PHYSICIAN OBSERVED APPROXIMATELY 10 ML OF FREE AIR ON THE DISPLAYED IMAGES. AFTER AN UNDISCLOSED PERIOD, THE PATIENT WAS SENT FOR A FOLLOW-UP CT SCAN. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 18779380 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BAYER MEDICAL CARE INC. WAS INFORMED OF AN ALLEGED AIR INJECTION WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR OBSERVATION AND HAS SINCE RECOVERED.

  Patient problems: Air Embolism

  MAUDE report 18041335 ↗
• InjuryOct 23, 2023Adverse 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 MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). AN ESTIMATED 56 ML OF CONTRAST EXTRAVASATED AT THE INJECTION SITE. A COLD COMPRESS WAS APPLIED TO THE AFFECTED EXTREMITY AND AN ULTRASOUND EXAMINATION WAS PERFORMED THE FOLLOWING DAY WHICH CONFIRMED THAT THE ISSUE HAD RESOLVED.

  Patient problems: Extravasation; Infiltration into Tissue

  MAUDE report 17986637 ↗
• DeathFeb 9, 2023Adverse 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 WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN 310749). THE CUSTOMER SITE REPORTED THAT A PATIENT WAS UNDERGOING AN EMERGENT CT SCAN. AFTER THE INJECTION OF CONTRAST, THE STELLANT INJECTOR DISPLAYED AN ERROR MESSAGE THAT INTERRUPTED THE POST-CONTRAST SALINE INJECTION. SIMULTANEOUS TO THIS, THE PATIENT'S HEALTH STATUS DECLINED RAPIDLY, AND THEY CEASED TO BREATHE. A BAYER CLINICAL APPLICATIONS SPECIALIST SPOKE TO THE RADIOLOGIST WHO WAS PRESENT DURING THE UNFORTUNATE INCIDENT AND WHO CONFIRMED THAT PATIENT'S DEMISE WAS CAUSED BY AN AORTIC RUPTURE AND NOT BY THE INTERRUPTED INJECTION.

  Patient problems: Great Vessel Perforation

  MAUDE report 16342192 ↗
• 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 ↗

Other Bayer Medical Care Inc. products

• MEDRAD Stellant FLEX Syringe Kit6 models · 13 reports · 2 recalls
• MEDRAD Stellant Sterile Disposable Syringe15 models · 61 reports