FastLoad CTA Dual Syringe PackRecalls & reported problems across all models
Bracco Injeneering SA · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of FastLoad CTA Dual Syringe Pack by Bracco Injeneering SA in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2017 and Apr 1, 2025 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
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
Most reported FastLoad CTA Dual Syringe Pack problems
Device problems
- Device Handling Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information2
- No Patient Involvement1
FastLoad CTA Dual Syringe Pack models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FastLoad™ CTA Dual Syringe Pack 017354Injector And Syringe, Angiographic20 reports
- FastLoad™ CTA Dual Syringe Pack 017346Injector And Syringe, Angiographic1 report
Recent FastLoad CTA Dual Syringe Pack adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025
WHITE TABS ON SYRINGE BROKE OFF WHILE LOADING CONTRAST. NO HARM TO PATIENT. DELAY IN CARE DUE TO HAVING TO SHUT DOWN INJECTOR AND REPLACE WITH SPARE. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SERVICE PROFESSIONALS HAVE BEEN PRESENT IN THE FACILITY TO CHECK INJECTORS, THINK THIS MAY BE A SYRINGE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21738199 ↗MalfunctionMar 26, 2025
WHITE PLASTIC PIECES OF CTA [COMPUTED TOMOGRAPHY ANGIOGRAPHY] SYRINGE BROKE OFF AND DISLODGED PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696523 ↗MalfunctionMar 25, 2025
WHEN I WAS ATTEMPTING TO LOAD CONTRAST INTO THE CONTRAST SYRINGE, I LITERALLY SAW THE WHITE PLASTIC TABS BREAK OFF INSIDE THE SYRINGE, AND AS THE PISTON WAS GOING DOWN AS THE CONTRAST WAS FILLING, IT GOT OFF LEVEL AND I HAD TO STOP WHAT I WAS DOING AND REMOVE THE BROKEN SYRINGE. I THEN HAD TO TURN THE MACHINE OFF, AND BACK ON, AND MANUALLY TWIST THE KNOB TO BRING THE PISTON BACK DOWN AND START ALL OVER. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SERVICE TEAM MEMBER COMING TO INSPECT THE INJECTOR, SERVICE TEAM TO LOOK AT THE SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686773 ↗MalfunctionMar 25, 2025
THE INJECTOR DOORS THAT HOLD THE SYRINGE ON THE INJECTOR MALFUNCTIONED ON THE CONTRAST SIDE. THERE IS A SILVER BUTTON THAT LOCKS THE DOOR, THIS SILVER BUTTON WAS STICKING OUT AND WE WERE UNABLE TO CLOSE THE DOOR. AFTER REBOOTING THE INJECTOR AND CHANGING THE SYRINGES, THE INJECTOR DOOR DID SHUT AND FUNCTIONED AS NORMAL. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SENDING SERVICE REP/TEAM TO EVALUATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686772 ↗MalfunctionMar 25, 2025
INJECTOR WAS FILLED PER PROTOCOL WITHOUT ANY ISSUES. PATIENT WAS HOOKED TO THE INJECTOR FOR THE SCAN. WHEN THE TECH STARTED THE INJECTION, THEY HEARD A "POP", THE TECH IMMEDIATELY STOPPED THE INJECTOR (IT DID NOT STOP ON ITS OWN). UPON INVESTIGATING THE SYRINGE WAS BUSTED ON THE CONTRAST SIDE. THE TECH UNHOOKED FROM THE TUBING AND REMOVED ALL PIECES. INFORMATION WAS SENT TO BRACCO & RISK MANAGEMENT. THE PATIENT WAS NOT HARMED BY THIS ERROR. PATIENT'S SCAN WAS THEN FINISHED WITHOUT ANY OTHER ISSUES. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SERVICE STAFF COMING TO INSPECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686649 ↗MalfunctionDec 3, 2024
PATIENT WAS ON THE CT TABLE READY FOR THE INJECTION OF CONTRAST DYE, UPON STARTING THE INJECTION, STAFF HEARD A POP. THE TECHS STOPPED THE INJECTION AND IMAGING, THE SYRINGE ON THE CONTRAST SIDE HAD BUSTED TOWARDS THE BOTTOM OF THE SYRINGE. EXAM WAS NOT COMPLETE, WE HAD TO LOAD THE INJECTOR AND RESTART THE PATIENTS SCAN. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832117 ↗MalfunctionNov 22, 2024
IN RADIOLOGY CT, UPON LOADING THE CONTRAST & SALINE IN THE SYRINGES THE WHITE PIECES WERE BROKEN OFF, AND THE BLACK SYRINGE HEAD DID NOT MOVE TO LOAD. THIS WAS NEVER HOOKED TO A PATIENT AND NO HARM WAS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20757251 ↗MalfunctionOct 31, 2024
> 80-YEAR-OLD FEMALE WITH HISTORY OF HYPERTENSION, DEGENERATIVE JOINT DISEASE, HYPERLIPIDEMIA PRESENTED TO ER (EMERGENCY ROOM). CT OF ABDOMEN/PELVIS WITH CONTRAST ORDERED. DURING CT TEST, TECHNICIAN WENT INTO ROOM TO START CONTRAST INJECTION. AS SOON AS THE TECHNICIAN STARTED THE INJECTION OF SALINE, THE CONTRAST INJECTOR EXPLODED AND CAUSED FRAGMENTS OF PLASTIC TO BREAK. FORTUNATELY, THE PATIENT (WHO WAS HOOKED UP TO THE INJECTOR) AND CT TECH WERE NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577319 ↗MalfunctionOct 31, 2024
WHILE SCANNING A CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) CORONARY STUDY, THE CONTRAST WAS HOOKED UP TO THE PATIENT'S IV. AS SOON AS THE INJECTION STARTED, WE HEARD A LOUD NOISE WHICH TURNED OUT TO BE THE INJECTOR (CONTRAST SIDE) EXPLODING AND CAUSING A PIECE OF ITS PLASTIC BASE TO COME APART AND FALL ONTO THE FLOOR. THE PATIENT WAS UNHARMED, BUT IT DID DELAY THE SCAN TIME AND COULD HAVE POSED A PHYSICAL RISK TO PATIENT AND STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577068 ↗MalfunctionSep 20, 2024
(B)(6)-YEAR-OLD FEMALE FOR PROCEDURE: CT OF THE CHEST. SYRINGES INSPECTED DURING SET UP WITH NO VISIBLE DEFECTS. INJECTOR INITIATED. INJECTOR MONITOR ALARMED SLIGHTLY FOR PRESSURE LIMIT. THE RATE OF INJECTION WAS 2.5 ML/SEC. ONCE THE ALARM WENT OFF, THE INJECTOR SLOWED INJECTION TO 1.5 ML/SEC. UPON INSPECTION, THE SYRINGE ON THE SALINE SIDE WAS BROKEN. NO KNOWN HARM TO PATIENT. EXAM DID NOT REQUIRE REPEATING. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). WILL OBTAIN.
Patient problems: Insufficient Information
MAUDE report 20266668 ↗MalfunctionAug 27, 2024
ELDERLY FEMALE WITH RECENT BLURRED VISION AND PARESTHESIA. PROCEDURE: CT HEAD. SCAN COW (CIRCLE OF WILLIS)/CAROTID AND TIMING BOLUS WAS FAINT AND HARD TO DETERMINE ON SCREEN. OBSERVATION IN SCAN ROOM IDENTIFIED MINIMAL AMOUNT OF CONTRAST GOT TO PATIENT, THE MAJORITY OF THE CONTRAST WAS ON THE FLOOR. LEAK OF CONTRAST FROM TUBING SITE OR CONNECTION UNIDENTIFIED. PATIENT RECEIVED A RELOAD OF CONTRAST AND AN ADDITIONAL 20CC AND ADMINISTERED ANOTHER TIMING BOLUS. NO KNOWN HARM TO PATIENT BUT DELAY IN PATIENT CARE. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075095 ↗MalfunctionAug 27, 2024
ELDERLY MALE. PROCEDURE: CT ANGIOPLASTY CHEST WITH CONTRAST. CONTRAST LEAKED FROM INJECTOR/TUBING CONNECTION DURING THE INJECTION. TUBING SECURE PRIOR TO INJECTION BUT UNABLE TO SEE SITE OF LEAKAGE. NO KNOWN INJURY TO PATIENT. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075091 ↗MalfunctionAug 27, 2024
TEENAGED MALE RECEIVING CT OF RIGHT AND LEFT FEMUR. RATE SET AT 1.5ML/SECOND. THERE WAS NO ERROR OUT OR STOP. THE SYRINGE BURST AND POPPED. THERE WAS NO ALARM. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075085 ↗MalfunctionAug 27, 2024
PROCEDURE: CT, NEW BRACCO- FASTLOAD CTA DUAL SYRINGE PACK OPENED- MISSING 1 SYRINGE CAP AND TUBING. NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD¿ CTA DUAL SYRINGE PACK (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075048 ↗MalfunctionAug 27, 2024
PROCEDURE: CT, NEW BRACCO- FASTLOAD CTA DUAL SYRINGE PACK OPENED- MISSING STRAW AND TUBING. NOT USED ON PATIENT. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER), WILL OBTAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075009 ↗
Other Bracco Injeneering SA products
All Bracco Injeneering SA 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.
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