MEDRAD Stellant Sterile Disposable SyringeRecalls & reported problems across all models
Bayer Medical Care Inc. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 15 models of MEDRAD Stellant Sterile Disposable Syringe by Bayer Medical Care Inc. in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Jan 11, 2017 and Nov 4, 2021 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (22 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 Sterile Disposable Syringe problems
Device problems
- Manufacturing, Packaging or Shipping Problem22
- Device Contamination with Chemical or Other Material13
- Product Quality Problem13
- Contamination /Decontamination Problem7
- Device Contaminated During Manufacture or Shipping7
- Break4
- Particulates4
- Air Leak1
Patient problems
- No Known Impact Or Consequence To Patient20
- No Patient Involvement16
- Not Applicable16
- No Clinical Signs, Symptoms or Conditions6
- No Information3
- No Code Available1
- No Consequences Or Impact To Patient1
MEDRAD Stellant Sterile Disposable Syringe models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKInjector And Syringe, Angiographic12 reports
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-SPKInjector And Syringe, Angiographic11 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKInjector And Syringe, Angiographic8 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-QFTInjector And Syringe, Angiographic6 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKInjector And Syringe, Angiographic6 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SCSInjector And Syringe, Angiographic5 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKInjector And Syringe, Angiographic3 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-QFTInjector And Syringe, Angiographic2 reports
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-SPKInjector And Syringe, Angiographic2 reports
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-QFTInjector And Syringe, Angiographic1 report
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-SPKInjector And Syringe, Angiographic1 report
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-QFTInjector And Syringe, Angiographic1 report
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-QFTInjector And Syringe, Angiographic1 report
- MEDRAD® Stellant Sterile Disposable Syringe SJS-PT-JInjector And Syringe, Angiographic1 report
- MEDRAD® Stellant Sterile Disposable Syringe FLEXD-150-SPKInjector And Syringe, Angiographic1 report
Recent MEDRAD Stellant Sterile Disposable Syringe adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT 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 12751908 ↗MalfunctionJul 29, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE SITE REPORTED THE FOLLOWING: AFTER FILLING THE CT SYRINGE WITH SALINE, THE TECHNOLOGIST NOTICED A THIN, HAIR-LIKE FOREIGN BODY WITHIN THE SYRINGE BARREL. 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 12248827 ↗MalfunctionJul 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: A FOREIGN MATERIAL WAS OBSERVED IN A STELLANT SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12128167 ↗MalfunctionMay 4, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: A FOREIGN MATERIAL WAS OBSERVED IN A STELLANT SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11770842 ↗MalfunctionApr 30, 2021Break
MEDRAD SYRINGE FOR CONTRAST POWER INJECTOR BROKE DURING POWER INJECTION. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11759809 ↗MalfunctionFeb 18, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW AN UNKNOWN PARTICULATE WITHIN THE MALE LUER CONNECTOR OF 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 11343696 ↗MalfunctionJun 15, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE SSS-CTP-SPK 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 Patient Involvement
MAUDE report 10153084 ↗MalfunctionApr 10, 2020Break
ELDERLY FEMALE WITH HISTORY OF TYPE 2 DIABETES, HYPERTENSION AND CONGESTIVE HEART FAILURE. PATIENT WAS HAVING A CT ANGIO OF CHEST, "INJECTOR WAS SET TO INJECT A PATIENT AT 5CC/SEC WITH A TOTAL OF 94CC, THE SALINE FLUSH WORKED FINE, THEN WHEN THE CONTRAST STARTED ONLY 1 CC WAS INJECTED AND THEN THE SYRINGE BROKE AT THE BOTTOM. THE INJECTOR WAS RELOADED AND PATIENT'S EXAM WAS THEN FINISHED WITHOUT FURTHER INCIDENT".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9948502 ↗MalfunctionMar 23, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN PARTICLE WITHIN THE SYRINGE BARREL. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9868353 ↗MalfunctionMar 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT AND UPON INSPECTION, THEY NOTICED THE PRESENCE OF FINE WHITE PARTICLES AROUND THE SYRINGE. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9852888 ↗MalfunctionMar 12, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING A STELLANT CT DISPOSABLE SYRINGE KIT A FOREIGN MATERIAL WAS VISUALIZED IN THE TUBING. THE CUSTOMER ELECTED NOT TO USE THE SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9824178 ↗MalfunctionDec 4, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT THE CUSTOMER OBSERVED A FOREIGN MATERIAL ON THE SPIKE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement; Not Applicable
MAUDE report 9412789 ↗MalfunctionOct 24, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT, THE CUSTOMER OBSERVED A FOREIGN BODY INSIDE THE TUBING. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9235346 ↗MalfunctionOct 22, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT 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. NOTE: ON OCTOBER 17, 2019, WE RECEIVED A COPY OF MEDWATCH (MW5090081).
Patient problems: No Patient Involvement
MAUDE report 9218432 ↗MalfunctionOct 11, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE STELLANT CT DISPOSABLE KIT THE CUSTOMER OBSERVED A FOREIGN MATERIAL UNDER THE BLUE DUST CAP ON THE SPIKE. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: Not Applicable
MAUDE report 9180011 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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