MEDRAD® Stellant FLEX Syringe Kit FLEXS-150-QFTRecalls & reported problems
Bayer Medical Care Inc. · STLNT,KIT,SYR,CT,S,QFT,FLS3,150ML,WLD (87078825) · Class 2
All models of MEDRAD Stellant FLEX Syringe Kit (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258022895), received between Feb 27, 2026 and Feb 27, 2026 — classified as 1 malfunction.
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jul 31, 2026Class IIOpen, 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 ↗
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
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 · TerminatedMAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Inje
Other Injector And Syringe, Angiographic devices
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- Monarch® 00884450298053Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- Monarch® 00884450298060Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- NAMIC 80085007Medline Industries, Inc. · Injector and syringe, angiographic1 recall36 reports
- NA 622510B. Braun Medical Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC85 reports
- NAMIC 80087007Medline Industries, Inc. · Injector and syringe, angiographic1 recall20 reports
- Blue Diamond™ 00884450381168Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC1 recall6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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