MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00616258011219), received between May 26, 2021 and May 1, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K173773); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED ON APRIL 7, 2026, OF AN EVENT THAT OCCURRED ON (B)(6) 2026, INVOLVING A 47-YEAR-OLD MALE PATIENT WHO UNDERWENT A CT EXAMINATION OF THE ABDOMEN AND PELVIS USING A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SERIAL NUMBER (B)(6)). A 20 GAUGE INTRAVENOUS CATHETER WAS PLACED IN THE PATIENT'S LEFT ANTECUBITAL VEIN. DURING CONTRAST INJECTION, THE PATIENT REPORTED PAIN, AND APPROXIMATELY 50 ML OF CONTRAST WAS REPORTED TO HAVE EXTRAVASATED INTO THE LEFT UPPER ARM. POST EVENT CARE INCLUDED ELEVATION OF THE AFFECTED LIMB AND APPLICATION OF COLD COMPRESSES. THE PATIENT LATER PRESENTED TO AN URGENT CARE FACILITY ON THE SAME EVENING, REPORTING NUMBNESS IN THE HANDS AND FINGERS WITH INCREASING PAIN. DURING FOLLOW UP THE NEXT DAY, THE PATIENT REPORTED THAT SYMPTOMS HAD BEEN RESOLVED.

  Patient problems: Extravasation

  MAUDE report 25055981 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A 17-YEAR-OLD MALE PATIENT IN THE EMERGENCY DEPARTMENT UNDERWENT A CONTRAST-ENHANCED CT SCAN. THE PROCEDURE WAS PERFORMED USING A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING COMPLETION OF THE CONTRAST INJECTION, AN UNDETERMINED AMOUNT OF AIR WAS VISUALIZED ON THE ACQUIRED CT IMAGES. OXYGEN WAS ADMINISTERED AND THE PATIENT WAS SUBSEQUENTLY ADMITTED FOR OBSERVATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 24277546 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER: (B)(6). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 24-HOUR OBSERVATION. THE PATIENT THEN UNDERWENT A REPEAT CT SCAN THE FOLLOWING DAY WHICH CONFIRMED THAT THE AIR HAD BEEN RESOLVED AND WAS SUBSEQUENTLY DISCHARGED TO HOME WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Air Embolism

  MAUDE report 23582681 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE PATIENT WAS PLACED IN LEFT LATERAL DECUBITUS POSITION, ADMINISTERED SUPPLEMENTAL OXYGEN AT 15L, AND ADMITTED TO THE INTENSIVE CARE UNIT FOR TELEMETRY AND MONITORING. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Air Embolism

  MAUDE report 23390406 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 73-YEAR-OLD MALE UNDERGOING A CT SCAN EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, THE CUSTOMER HAD REPORTED SEEING AIR BUBBLES ON THE DISPLAYED IMAGES WITHIN THE RIGHT VENTRICLE, THE RIGHT SUB-CLAVICULAR REGION, AND IN THE SUPERIOR VENA CAVA. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND RECEIVED FOLLOW-UP IMAGING WHICH SHOWED THAT THE AIR HAD RESOLVED. THE PATIENT IS REPORTED AS DOING WELL.

  Patient problems: Air Embolism

  MAUDE report 22902134 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS INFORMED THAT A 44-YEAR-OLD FEMALE SUFFERED AN EXTRAVASATION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6). THE CUSTOMER REPORTED THAT APPROXIMATELY 16 ML OF FLUID WAS EXTRAVASATED IN THE PATIENT'S RIGHT ANTECUBITAL. FOLLOWING THE EVENT, A WARM COMPRESS WAS APPLIED TO THE INFILTRATION SITE, A RADIOLOGIST ASSESSED THE PATIENT IV SITE, AND AN X-RAY WAS PERFORMED TO DOCUMENT THE EXTENT OF THE EXTRAVASATION. THE PATIENT IS REPORTED AS DOING WELL.

  Patient problems: Extravasation

  MAUDE report 22143527 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS INFORMED THAT A 50-YEAR-OLD FEMALE SUFFERED AN EXTRAVASATION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (B)(6). THE CUSTOMER REPORTED THAT APPROXIMATELY 100 ML OF CONTRAST WAS EXTRAVASATED IN THE PATIENT'S LEFT ANTECUBITAL. FOLLOWING THE EVENT, THE AFFECTED LIMB WAS ELEVATED, A WARM COMPRESS WAS APPLIED TO THE INFILTRATION SITE, AND ACETAMINOPHEN WAS RECOMMENDED. AFTER BEING DISCHARGED, THE PATIENT HAD VISITED AN EMERGENCY DEPARTMENT ON A RECOMMENDATION FROM THE SITE RADIOLOGY NURSE, DUE TO LEAKAGE FROM THE EXTRAVASATION SITE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 20278569 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 54-YEAR-OLD FEMALE UNDERGOING A CT SCAN WITH CONTRAST SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). IT WAS REPORTED THAT AN ESTIMATED 15-20 ML OF AIR WAS NOTICED ON THE DISPLAYED IMAGES. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FROM THE EMERGENCY DEPARTMENT, AND AFTER AN UNDISCLOSED PERIOD OF TIME, THE PATIENT WAS DISCHARGED TO HOME WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Air Embolism

  MAUDE report 19721943 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 74-YEAR-OLD MALE INPATIENT UNDERGOING A CT SCAN FOR A PULMONARY EMBOLISM SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). IT WAS REPORTED THAT AN ESTIMATED 5 ML OF AIR WAS NOTICED ON THE DISPLAYED IMAGES. FOLLOWING THE EVENT, THE PATIENT WAS REPORTED TO HAVE BEEN INTUBATED AND, AFTER AN UNDISCLOSED PERIOD OF TIME, THE PATIENT WAS DISCHARGED TO HOME WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Air Embolism

  MAUDE report 19720151 ↗
• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT AN 87-YEAR-OLD FEMALE UNDERGOING A CT SCAN OF THE CHEST SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6)). AFTER RECEIVING AN UNDISCLOSED AMOUNT OF AIR, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH WITH DECREASING OXYGEN SATURATION. SUPPLEMENTAL OXYGEN WAS ADMINISTERED, AND THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR FURTHER CARE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED AND WAS REPORTED TO BE DOING WELL WITH NO FURTHER ISSUES REPORTED. NOTE: BAYER MEDICAL CARE INC. RECEIVED A MEDWATCH (MW5158297) FOR THIS ISSUE ON SEPTEMBER 3, 2024.

  Patient problems: Air Embolism

  MAUDE report 19681041 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: A 23-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF SICKLE CELL DISEASE WAS UNDERGOING AN ENHANCED CT SCAN OF THE CHEST FOR SUSPECTED PULMONARY ARTERIAL AIR EMBOLI WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6). DURING THE CONTRAST INJECTION, THE TECHNOLOGIST NOTICED THAT THERE WAS NO INCREASE IN PRESSURE, SO THE PROCEDURE WAS HALTED AND, WHEN EVALUATING THE PATIENT, THE TECHNOLOGIST OBSERVED THAT THERE HAD BEEN A LEAKAGE OF CONTRAST ONTO THE TABLE BEHIND THE PATIENT'S HEAD. AFTER REPLACING THE DISPOSABLES, THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE RADIOLOGIST REVIEWED THE IMAGES AND REPORTED THAT AIR WAS VISUALIZED. THE PATIENT WAS SUBSEQUENTLY PLACED INTO HYPERBARIC OXYGEN PROTOCOL WITH ADMINISTRATION OF HIGH FLOW OXYGEN AND CLOSE OBSERVATION. A REPEAT CT SCAN WAS PERFORMED, AND THE PATIENT IS REPORTED TO HAVE BEEN DISCHARGED WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Air Embolism

  MAUDE report 19171735 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF AN EXTRAVASATION OCCURRING DURING A CARDIAC CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM. THE CUSTOMER REPORTED THAT APPROXIMATELY 130ML OF CONTRAST WAS EXTRAVASATED IN THE PATIENT'S LEFT FOREARM DURING THE INJECTION. THE PATIENT UNDERWENT A FASCIOTOMY, AND AN ULTRASOUND WAS PERFORMED WHICH CONFIRMED THAT VASCULAR AND ARTERIAL BLOOD FLOW HAD BEEN MAINTAINED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Extravasation

  MAUDE report 18856615 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). A 32-YEAR OLD MALE PATIENT FROM THE EMERGENCY DEPARTMENT WAS UNDERGOING A CT WITH CONTRAST OF THE ABDOMEN AND PELVIS FOR A CHIEF COMPLAINT OF LEFT LOWER QUADRANT (LLQ) PAIN. DURING THE PROCEDURE, APPROXIMATELY 90CC OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AND WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER FACILITY TO UNDERGO HYPERBARIC OXYGEN THERAPY. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Air Embolism

  MAUDE report 17896204 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT OCCURRED WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN 100176). A 73-YEAR-OLD MALE PATIENT WAS UNDERGOING A CT WITH CONTRAST, OF THE ABDOMEN AND PELVIS FOR A CHIEF COMPLAINT OF CONSTIPATION. UPON COMPLETION OF THE PROCEDURE, THE PATIENT REPORTED THAT HE "DIDN'T FEEL WELL" AT WHICH TIME A RAPID RESPONSE WAS CALLED. THE PATIENT BECAME UNRESPONSIVE, WAS INTUBATED, PLACED ON A VENTILATOR, GIVEN UNDISCLOSED EMERGENCY TREATMENT, AND SUBSEQUENTLY RETURNED TO THE EMERGENCY DEPARTMENT FOR FURTHER CARE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR CONTINUED TREATMENT AND MONITORING. AIR WAS REPORTED TO BE VISUALIZED ON THE DISPLAYED IMAGES. THE FOLLOWING DAY, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO UNDERGO HYPERBARIC OXYGEN THERAPY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 17558997 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS NOTIFIED OF AN ALLEGED AIR INJECTION THAT HAD OCCURRED DURING A CT SCAN WHILE THE PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)). AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT STATED THAT THEY WEREN'T FEELING WELL. A FOLLOW-UP CT SCAN WAS PERFORMED AT WHICH TIME AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. THE DISPOSITION AND CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 17475188 ↗
• InjuryNov 14, 2022Adverse 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 FLEX INJECTION SYSTEM. POST INJECTION, THE CUSTOMER REPORTED THAT APPROXIMATELY 60 ML OF CONTRAST EXTRAVASATED AT THE PATIENT'S RIGHT ANTECUBITAL INJECTION SITE. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION/OBSERVATION. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED TO HOME AFTER TWO DAYS WITH NO FURTHER MEDICAL INTERVENTION NECESSITATED.

  Patient problems: Extravasation; Infiltration into Tissue

  MAUDE report 15787589 ↗
• InjurySep 13, 2022Adverse 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 FLEX INJECTION SYSTEM. POST INJECTION, THE CUSTOMER REPORTED THAT APPROXIMATELY 70 ML OF CONTRAST EXTRAVASATED AT THE PATIENT'S LEFT ANTECUBITAL INJECTION SITE. THE AFFECTED EXTREMITY WAS ELEVATED, AND ICE/WARM COMPRESSES WERE APPLIED. THE PATIENT WAS TRANSPORTED BY VEHICLE TO THE ORDERING PHYSICIAN'S OFFICE FOR FURTHER EVALUATION. POST CARE INSTRUCTIONS WERE PROVIDED, AND THE PATIENT WAS REPORTEDLY WAITING FOR THE SWELLING AND PAIN TO SUBSIDE.

  Patient problems: Infiltration into Tissue

  MAUDE report 15412536 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, BAYER MEDICAL CARE RECEIVED INFORMATION THAT AN (B)(6) MALE PATIENT WHO WAS UNDERGOING A CT SCAN SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A STELLANT FLEX INJECTOR SYSTEM. POST PROCEDURE, WHEN VIEWING THE IMAGES, THE RADIOLOGIST NOTED A LARGE AMOUNT OF AIR WITHIN THE PATIENT'S CIRCULATORY SYSTEM. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC, HE WAS TRANSFERRED TO ANOTHER FACILITY AND RECEIVED A 6-HOUR HYPERBARIC TREATMENT AND WAS NOTED TO HAVE 208 MLS AIR IN HIS CIRCULATORY SYSTEM. THE PATIENT REPORTEDLY RECOVERED AND WAS DISCHARGED TO HOME.

  Patient problems: Air Embolism

  MAUDE report 13498492 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLLOWING: AS THE STAFF WAS PREPARING THE STELLANT FLEX SYSTEM (SERIAL NUMBER (B)(4)) FOR A PROCEDURE, THE INJECTOR HEAD DISENGAGED FROM THE OCS III SYSTEM (SERIAL (B)(4)). NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173773. 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