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 16 adverse event reports that list this exact device (DI 00616258020860), received between Dec 16, 2019 and Feb 20, 2026 — classified as 2 deaths, 14 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE RECEIVED INFORMATION THAT A 70-YEAR-OLD FEMALE PATIENT WHO WAS UNDERGOING A CT SCAN OF THE CHEST WITH CONTRAST SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM. THE CUSTOMER REPORTED THAT APPROXIMATELY 40-50 MLS OF ALLEGED AIR WAS VISUALIZED BY THE RADIOLOGIST IN THE PATIENT'S HEART WHEN REVIEWING THE IMAGES. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS ADMITTED FOR OBSERVATION OVERNIGHT AND THEN DISCHARGED THE NEXT DAY. NO ADDITIONAL TREATMENT WAS NECESSARY.

  Patient problems: Air Embolism

  MAUDE report 15580271 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AN 8-YEAR OLD MALE WITH A HISTORY OF CANCER WAS UNDERGOING A CT SCAN OF THE CHEST TO EVALUATE FOR METASTASES. THE PATIENT HAD A HICKMAN DUAL LUMEN PORT IMPLANTED IN THE UPPER CHEST AREA TO WHICH THE STELLANT CT INJECTOR SYSTEM (SN (B)(4)) WAS CONNECTED. AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, THE PATIENT WAS EVALUATED AND FOUND TO HAVE A LARGE SWOLLEN AREA OVER THE PORT SITE. THE CUSTOMER REPORTED THAT ONE OF THE LUMENS OF THE PORT WAS DAMAGED DURING THE INJECTION AFTER WHICH THE PATIENT REQUIRED SURGICAL REMOVAL AND REPLACEMENT OF THE PORT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 14433944 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAYER REPRESENTATIVE RECEIVED THE FOLLOWING INFORMATION: A (B)(6) YEAR OLD MALE PATIENT WITH HISTORY OF CAROTID STENOSIS UNDERWENT A CTA OF THE CAROTID ARTERIES WHILE CONNECTED TO A STELLANT CT INJECTOR SYSTEM. DURING THE INJECTION THE PATIENT SUFFERED AN EXTRAVASATION OF CONTRAST, EXACT AMOUNT UNKNOWN. POST PROCEDURE, THE PATIENT WAS TREATED WITH A COLD COMPRESS, DERMATOLOGY WAS CONSULTED, AND CORTICOSTEROIDS WERE ADMINISTERED. NO FURTHER MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Extravasation

  MAUDE report 10343883 ↗
• InjuryJul 16, 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 ON AN ELDERLY FEMALE PATIENT WHILE CONNECTED TO A STELLANT CT INJECTION SYSTEM. THE CUSTOMER REPORTED AN UNDISCLOSED AMOUNT OF CONTRAST HAD EXTRAVASATED DURING THE PROCEDURE AT THE PATIENT'S IV (INTRAVENOUS SITE) CATHETER LOCATION. THE IV CATHETER WAS SUBSEQUENTLY REMOVED AND A NEW ONE WAS STARTED AFTER WHICH THE INJECTION AND SCAN WERE SUCCESSFULLY COMPLETED. POST PROCEDURE, THE PATIENT WAS TREATED AT AN OUTPATIENT DEPARTMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 10282914 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A PATIENT WAS UNDERGOING A CT SCAN WHILE CONNECTED TO A STELLANT CT INJECTION SYSTEM. DURING THE INJECTION, APPROXIMATELY 10-20CC OF AIR WAS VISUALIZED ON THE SUBSEQUENT IMAGES. THE PATIENT WAS ASYMPTOMATIC; HOWEVER, THEY WERE ADMITTED TO AN INPATIENT UNIT FOR OBSERVATION AND WAS DISCHARGED TO HOME THE FOLLOWING DAY WITHOUT FURTHER ISSUE.

  Patient problems: Air Embolism

  MAUDE report 9474854 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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