FastLoad™ MR Syringe Pack 017356Recalls & reported problems
Bracco Injeneering SA · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 17630039300866), received between Aug 27, 2024 and Nov 6, 2024 — classified as 4 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2024
MRI STAFF OPENED A BRAND-NEW POWER INJECTOR KIT. ONE OF THE SYRINGES- PLUNGER/STOPPER WAS NOT ALIGNED RIGHT. THE OTHER SYRINGE WAS MISSING A FLANGE. KIT NOT USED ON ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20619855 ↗MalfunctionSep 20, 2024
POWER INJECTOR SYRINGE LEAKED OUT OF BOTTOM OF SYRINGE INTO INJECTOR AFTER UNHOOKING FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266320 ↗MalfunctionSep 20, 2024
FAULTY POWER INJECTOR SYRINGE-PLUNGER PORTION INSIDE OF SYRINGE TWISTED SIDEWAYS AFTER UNHOOKING FROM PATIENT. SALINE/CONTRAST LEAKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20266310 ↗MalfunctionAug 27, 2024
PROCEDURE: MRI SUCCESSFUL INJECTION, WHEN DRAWING BACK ON SYRINGE TO REMOVE AND DISPOSE, THE PLUNGER TURNED SIDEWAYS, LETTING THE REMAINING SALINE IN SYRINGE SPILL ONTO INJECTOR HEAD AND FLOOR. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR INJECTOR, CONTRAST MEDIUM, AUTOMATIC, FASTLOAD MR SYRINGE PACK (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075495 ↗
Other Injector, Contrast Medium, Automatic devices
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPKBayer Medical Care Inc. · Injector, Contrast Medium, Automatic1 recall0 reports
- MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc. · Injector, Contrast Medium, Automatic19 reports
- MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade)Bayer Medical Care Inc. · Injector, Contrast Medium, Automatic16 reports
- LF 844005Liebel-Flarsheim Company LLC · Injector, Contrast Medium, Automatic6 reports
- EmpowerCTA®+ Injector System 017285Bracco Injeneering SA · Injector, Contrast Medium, Automatic2 deaths3 reports
- LF 844007Liebel-Flarsheim Company LLC · Injector, Contrast Medium, Automatic2 reports
- UL_INJECT XD 8000Ulrich GmbH & Co. KG · Injector, contrast medium, automatic1 death1 report
- EmpowerMR® Injector System without Remote Control 017377Bracco Injeneering SA · Injector, Contrast Medium, Automatic1 report
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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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