MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00616258020792), received between Mar 19, 2020 and Jul 14, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

• InjuryJul 14, 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 A 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 REPORTED TO HAVE BEEN TRANSFERRED TO ANOTHER FACILITY AND THEIR CURRENT STATUS IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 22494387 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 43-YEAR-OLD FEMALE UNDERGOING A CT OF THE CHEST HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). FOLLOWING COMPLETION OF THE PROCEDURE, THE CUSTOMER REPORTED THAT APPROXIMATELY 40 ML OF AIR WAS VIEWED ON THE DISPLAYED IMAGES. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND IS REPORTED AS BEING STABLE.

  Patient problems: Air Embolism

  MAUDE report 22297160 ↗
• InjuryJun 9, 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 CT INJECTION SYSTEM (B)(6). DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT APPROXIMATELY 93ML OF AIR WAS INJECTED AND THE PATIENT WAS REPORTED TO HAVE EXHIBITED COUGHING AND SHORTNESS OF BREATH. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER EVALUATION AND WAS DISCHARGED TO HOME THE FOLLOWING DAY WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Air Embolism

  MAUDE report 22168060 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 62-YEAR-OLD FEMALE UNDERGOING A CT OF THE CHEST, ABDOMEN AND PELVIS HAD EXPERIENCED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). FOLLOWING COMPLETION OF THE PROCEDURE, A RADIOLOGIST OBSERVED 18 ML OF AIR ON THE DISPLAYED IMAGES AND REQUESTED THAT THE PATIENT BE EVALUATED IN THE EMERGENCY DEPARTMENT. WHILE UNDER OBSERVATION, A FOLLOW-UP CT SCAN WAS PERFORMED WHICH SHOWED THAT THE AIR HAD RESOLVED. THE PATIENT IS REPORTED AS DOING WELL.

  Patient problems: Air Embolism

  MAUDE report 21412262 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE WAS INFORMED THAT A 72-YEAR-OLD FEMALE EXPERIENCED AN EXTRAVASATION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6). THE CUSTOMER REPORTED THAT APPROXIMATELY 150 ML OF FLUID WAS EXTRAVASATED IN THE PATIENT'S RIGHT ANTECUBITAL. FOLLOWING THE EVENT, THE AFFECTED LIMB WAS ELEVATED, A COLD COMPRESS WAS APPLIED TO THE INFILTRATION SITE, AND THE PATIENT WAS ADMITTED FOR OBSERVATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THE SITE CONTINUES TO USE THE INJECTOR AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Extravasation

  MAUDE report 20407160 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE INC. WAS INFORMED THAT A 30-YEAR-OLD MALE UNDERGOING A CT SCAN OF THE CHEST, ABDOMEN, AND PELVIS SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT THE RADIOLOGIST NOTICED LESS THAN 3 ML OF AIR ON THE DISPLAYED IMAGES. FOLLOWING COMPLETION OF THE PROCEDURE, THE RADIOLOGIST REQUESTED THAT THE PATIENT BE SENT TO THE EMERGENCY DEPARTMENT TO BE MONITORED. THE EMERGENCY DEPARTMENT ADMITTED THE PATIENT TO THE HOSPITAL OVERNIGHT, FOR OBSERVATION. THE PATIENT WAS REPORTED AS STABLE AND WAS DISCHARGED HOME THE FOLLOWING DAY.

  Patient problems: Air Embolism

  MAUDE report 19003780 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 14, 2023 BAYER MEDICAL CARE INC. RECEIVED INFORMATION THAT A PATIENT WHO WAS UNDERGOING A CT SCAN SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (B)(6). THE PATIENT WAS REPORTED TO HAVE REQUIRED MEDICAL TREATMENT FOR THE AIR INJECTION. ALTHOUGH NO ADDITIONAL DETAILS WERE PROVIDED, THE CUSTOMER DID CONFIRM THAT THE PATIENT IS DOING FINE NOW.

  Patient problems: Air Embolism

  MAUDE report 18226883 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON NOVEMBER 21, 2023 BAYER MEDICAL CARE INC. RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE CUSTOMER: A 61-YEAR-OLD MALE SUFFERED AN AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6)). FOLLOWING THE INJECTION, THE TECHNOLOGIST NOTICED AN ABSENCE OF CONTRAST ON THE STUDY IMAGES. THE EMERGENCY DEPARTMENT PHYSICIAN VISUALIZED AN ESTIMATED 60-100 ML OF AIR ON THE DISPLAYED IMAGES. WHILE UNDER OBSERVATION IN THE EMERGENCY DEPARTMENT, THE PATIENT WAS GIVEN BENADRYL, PLACED IN LEFT LATERAL RECUMBENT TRENDELENBURG POSITION, AND HAD THEIR OXYGEN LEVEL INCREASED FROM 2 TO 6 LITERS VIA NASAL CANNULA. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO A CARDIAC UNIT FOR MONITORING AND WAS DISCHARGED TO HOME TWO DAYS LATER.

  Patient problems: Air Embolism

  MAUDE report 18192239 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 65-YEAR-OLD FEMALE PATIENT FROM THE EMERGENCY ROOM WAS UNDERGOING A CT SCAN OF THE ABDOMEN AND PELVIS WITH INTRAVENOUS CONTRAST ENHANCEMENT WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM. DURING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED WITHIN THE HEART ON THE DISPLAYED IMAGES. THE PATIENT BECAME UNRESPONSIVE AND WAS SUCCESSFULLY RESUSCITATED. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED FOR HYPERBARIC TREATMENT AND WAS REPORTED TO HAVE BEEN DISCHARGED TO A REHABILITATION UNIT WITH NO NEUROLOGICAL DEFICITS NOTED. NOTE: THIS EVENT OCCURRED ON (B)(6) 2023 AT WHICH TIME FEW DETAILS WERE PROVIDED REGARDING THE ALLEGED INCIDENT. AT THAT TIME, BAYER MEDICAL CARE MADE MULTIPLE UNSUCCESSFUL DOCUMENTED ATTEMPTS TO GAIN SPECIFIC INFORMATION RELATED TO THE INCIDENT. HOWEVER, ON (B)(6) 2023 BAYER RECEIVED ADDITIONAL INCIDENT DETAILS AFTER WHICH THE REPORTABILITY DETERMINATION WAS MADE.

  Patient problems: Air Embolism

  MAUDE report 17670698 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BAYER MEDICAL CARE RECEIVED INFORMATION THAT A 93-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A CT OF THE ABDOMEN AND PELVIS WITH IV CONTRAST FOR LEFT LOWER QUADRANT ABDOMINAL PAIN AND DIARRHEA SUFFERED AN AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT APPROXIMATELY 140 ML OF AIR WAS OBSERVED ON THE DISPLAYED IMAGES. FOLLOWING THE INJECTION, THE PATIENT WENT INTO CARDIAC ARREST, AFTER WHICH UNDISCLOSED MEDICAL INTERVENTION WAS PERFORMED. THE CUSTOMER REPORTED THAT THE PATIENT HAD BEEN DISCHARGED WITH NO FURTHER ISSUES REPORTED. BAYER MEDICAL CARE RECEIVED INFORMATION THAT A 93-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A CT OF THE ABDOMEN AND PELVIS WITH IV CONTRAST FOR LEFT LOWER QUADRANT ABDOMINAL PAIN AND DIARRHEA SUFFERED AN AIR INJECTION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6)). THE CUSTOMER REPORTED THAT APPROXIMATELY 140 ML OF AIR WAS OBSERVED ON THE DISPLAYED IMAGES. FOLLOWING THE INJECTION, THE PATIENT WENT INTO CARDIAC ARREST, AFTER WHICH UNDISCLOSED MEDICAL INTERVENTION WAS PERFORMED. THE CUSTOMER REPORTED THAT THE PATIENT HAD BEEN DISCHARGED WITH NO FURTHER ISSUES REPORTED.

  Patient problems: Air Embolism

  MAUDE report 17653552 ↗
• InjuryJun 8, 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). DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT APPROXIMATELY 100ML OF AIR WAS INJECTED. SUBSEQUENTLY THE PATIENT WAS REPORTED TO HAVE HAD DIFFICULTY BREATHING AND WAS TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT IN A HYPERBARIC CHAMBER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Embolism/Embolus

  MAUDE report 17092933 ↗
• InjuryMay 25, 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 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)). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT AT WHICH TIME A THORACIC SURGEON WAS CONSULTED. AFTER BEING EVALUATED BY THE THORACIC SURGEON, THE PATIENT WAS CONFIRMED TO BE FINE AND WAS SUBSEQUENTLY DISCHARGED TO HOME WITH NO FURTHER ISSUES REPORTED. BAYER MEDICAL CARE RECEIVED A MEDWATCH (MW5117517) ON MAY 22, 2023.

  Patient problems: Air Embolism

  MAUDE report 17003574 ↗
• InjuryApr 26, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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) ). FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE DISPLAYED IMAGES. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT AND UNDERWENT A CHEST-RAY AND LOWER EXTREMITY ULTRASOUND FOR PRECAUTION/OBSERVATION. THE CUSTOMER REPORTED THAT THEY HAVE NOT RECEIVED ANY FURTHER INFORMATION FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820134 ↗
• MalfunctionMar 3, 2022Detachment 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 (OCS III 0214/17677). NO INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660514 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING: AN OUTPATIENT UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS WITH CONTRAST WHILE CONNECTED TO A STELLANT FLEX CT INJECTION SYSTEM. FOLLOWING THE INJECTION, AN UNDISCLOSED AMOUNT OF AIR WAS VISUALIZED ON THE SUBSEQUENT IMAGES. THE EXACT ANATOMICAL LOCATION OF THE ALLEGED AIR WAS NOT DISCLOSED. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE RADIOLOGIST ORDERED A CT SCAN OF THE CHEST TO EVALUATE FOR AIR AFTER WHICH THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Air Embolism

  MAUDE report 12471092 ↗
• InjuryMar 19, 2020Human-Device Interface Problem; Human-Device Interface Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO BAYER: A SYRINGE BROKE WHILE A TECHNOLOGIST WAS ATTEMPTING TO REMOVE THE SYRINGE FROM THE STELLANT FLEX INJECTOR SYSTEM. FOLLOWING THE OCCURRENCE, A PORTION OF THE SYRINGE REMAINED ENGAGED WITHIN THE INJECTOR SYSTEM. THE TECHNOLOGIST USED A PAIR OF SCISSORS TO TRY AND RETRIEVE THE BROKEN PORTION OF THE SYRINGE AND IN DOING SO, PUNCTURED THE PALM OF HIS HAND WITH THE SCISSORS. A SAFETY REPORT WAS FILED AT THE CUSTOMER SITE AND THE TECHNOLOGIST WAS EVALUATED AT OCCUPATIONAL HEALTH THE MORNING AFTER THE INCIDENT OCCURRED. THE TECHNOLOGIST WAS GIVEN A TETANUS SHOT FOR PREVENTION AND INSTRUCTED TO FOLLOW UP WITH OCCUPATIONAL HEALTH AS NEEDED. THE TECHNOLOGIST HAS BEEN REPORTED TO RECOVER AND NO FURTHER TREATMENT HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9855994 ↗

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