MEDRAD Stellant FLEX Syringe KitRecalls & reported problems across all models
Bayer Medical Care Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MEDRAD Stellant FLEX Syringe Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 6 models of MEDRAD Stellant FLEX Syringe Kit by Bayer Medical Care Inc. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2020 and Feb 27, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
MEDRAD Stellant FLEX Syringe Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 31, 2026Open, Classified
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Z-3147-2026 · Root cause: Employee error · Recall details · FDA record ↗
- Oct 5, 2020Terminated
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Z-0483-2021 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported MEDRAD Stellant FLEX Syringe Kit problems
Device problems
- Leak/Splash2
- Manufacturing, Packaging or Shipping Problem2
- Material Puncture/Hole2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Connection Problem1
- Defective Device1
- Entrapment of Device1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions5
- Back pain1
- Chemical Exposure1
MEDRAD Stellant FLEX Syringe Kit models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SCSInjector And Syringe, Angiographic1 recall3 reports
- MEDRAD® Stellant FLEX Syringe Kit FLEXS-150-QFTInjector And Syringe, Angiographic1 recall1 report
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPKInjector, Contrast Medium, Automatic1 recall0 reports
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPKInjector And Syringe, Angiographic7 reports
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-200-SPKInjector And Syringe, Angiographic1 report
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPKInjector And Syringe, Angiographic1 report
Recent MEDRAD Stellant FLEX Syringe Kit adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026
THE IV CONTRAST COULD NOT BE ADMINISTERED THROUGH THE PROPER TUBING BECAUSE THE TUBING THAT CONNECTS TO THE SYRINGE WAS LEAKING. THE INJECTION WAS STOPPED AND THE TUBING WAS READJUSTED BUT DID NOT CORRECT THE ISSUE. THE CONTRAST WAS INITIALLY LEAKING BUT AS THE PRESSURE BUILT IT CAME OUT ALL OVER THE TECHNOLOGIST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469388 ↗MalfunctionMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED CONNECTION AND LEAKING ISSUES WHILE USING A MEDRAD® STELLANT FLEX DISPOSABLE SYRINGE KIT (FLEXD-150-SPK, LOT NUMBER 8659907). THE CONTRAST HAD LEAKED ONTO THE FLOOR UPON WHICH THE TECHNOLOGIST SUBSEQUENTLY SLIPPED AND FELL. AFTER BEING EVALUATED IN THE EMERGENCY ROOM, THE EMPLOYEE WAS RELEASED BACK TO WORK WITH NO ISSUES REPORTED.
Patient problems: Back pain
MAUDE report 21582422 ↗MalfunctionApr 16, 2024
MEDRAD STELLANT FLEX TUBING CRACKING/LEAKING. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127762 ↗MalfunctionJan 25, 2024
MEDRAD SYRINGE NOTED TO HAVE FLOATING SCRAP OF PLASTIC MATERIAL INSIDE ONE OF THE TWO SYRINGES.
Patient problems: Insufficient Information
MAUDE report 18578886 ↗MalfunctionMay 25, 2023Leak/Splash; Defective Device; Incomplete or Inadequate Connection
AT (B)(6) HOSPITAL, ON (B)(6) 2023 IN CT, CONTRAST SPRAYED OUT OF THE SYRINGE CONNECTION TUBING DURING A PATIENT INJECTION. THE CONTRAST CAME OUT OF A FIXED MANUFACTURER CONNECTION POINT, NOT FROM A CONNECTION POINT THAT THE STAFF CONNECTS MANUALLY. THE IS POTENTIALLY DANGEROUS BECAUSE IT COULD INTRODUCE AIR INTO THE PATIENT. IT COULD ALSO SPRAY CONTRAST INTO THE EYES OF A PATIENT. SYRINGE REF # FLEXD-150-SPK, LOT # 8624657, EXP DATE 2026-09-30.
Patient problems: Chemical Exposure
MAUDE report 17011216 ↗MalfunctionFeb 16, 2023Break
MEDRAD STELLANT FLEX SYRINGE OPENED FOR USE ON INJECTOR TUBING IN THE KIT WAS BROKEN AT THE SYRINGE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16398912 ↗MalfunctionDec 6, 2022Material Puncture/Hole
HOLE IN TUBING; 150ML STERILE DISPOSABLE SYRINGE. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 15932900 ↗MalfunctionAug 24, 2022Material Puncture/Hole
I PRIMED THE TUBING AGAIN AFTER IT WAS DISCONNECTED FROM THE PATIENT TO FIND A HOLE IN THE TUBING. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 15293180 ↗MalfunctionDec 8, 2021Material Separation
THERE HAVE BEEN 4 INSTANCES THIS WEEK IN THAT THE HUB OF THE EXTENSION TUBING HAS SEPARATED FROM THE TUBING ITSELF. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Insufficient Information
MAUDE report 12967551 ↗MalfunctionNov 4, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT FLEX CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE LOW PRESSURE CONNECTOR TUBING (LPCT). THE CUSTOMER ELECTED NOT TO USE THE TUBING. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12752547 ↗MalfunctionOct 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: A FOREIGN MATERIAL WAS OBSERVED IN A STELLANT FLEX SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12697905 ↗MalfunctionJun 23, 2021Entrapment of Device; Connection Problem
UPON LOADING FOR CONTRAST ON THE MEDRAD STELLANT INJECTOR, CT TECH OPENED A NEW AND SEALED DUAL SYRINGE KIT TO LOAD CONTRAST AND SALINE. SYRINGES WERE PLACED ON INJECTOR. TECH HAD DIFFICULTY TRYING TO ATTACH ENCLOSED SPIKE TO TIP OF SYRINGE. UPON CLOSER INSPECTION, TECH NOTICED A SMALL PLASTIC PIECE IN THE MALE LUER LOCK WELL OF THE THREADED SECTION OF THE TIP. THE SYRINGE WAS REMOVED FROM INJECTOR, PLASTIC PIECE WAS REMOVED FROM THE WELL AND NOT USED. NO PATIENT HARM. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Insufficient Information
MAUDE report 12057962 ↗MalfunctionOct 30, 2020Leak/Splash
MEDRAD STELLANT FLEX SYRINGES ARE CONSTANTLY LEAKING CONTRAST WHEN IN USE. CONTACTED (B)(4) AND STATED LOT 8586385 HAS KNOWN ISSUES, AND ALL SUPPLY SHOULD BE PULLED FROM BEING USED. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 10770196 ↗
Other Bayer Medical Care Inc. products
All Bayer Medical Care Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page