FastLoad™ CTA Dual Syringe Pack 017354Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 17630039300880), received between May 3, 2024 and Apr 1, 2025 — classified as 20 malfunctions.

1 other recall cover devices cleared under the same FDA submission (K933846); 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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, 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 ↗
• MalfunctionAug 27, 2024

  PROCEDURE: CT, NEW BRACCO- FASTLOAD CTA DUAL SYRINGE PACK OPENED- MISSING THE 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 20074979 ↗
• MalfunctionAug 27, 2024

  PROCEDURE: CT, DURING PROCEDURE, THE CONTRAST LEAKED FROM TUBING OR CONNECTION SITE OF TUBING/SYRINGE. DID HAVE TO RELOAD CONTRAST TO INJECT PATIENT. 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 20074960 ↗
• MalfunctionMay 23, 2024

  PROCEDURE: CT- BRACCO INJECTORS LOT#: 251454, INJECTORS OBTAINED TUBING CRACKS WHILE INJECTING, CONTRAST LEAKED ALL OVER. TUBES WERE NOT SAVED- NO KNOWN HARM TO STAFF OR PATIENT. PROCEDURE 2: CT- BRACCO INJECTOR TOP IS BROKEN OFF AND UNABLE TO LOAD CONTRAST IMMEDIATELY AFTER REMOVING FROM PACKAGING. NOT USED ON PATIENT. TUBES SAVED, PACKAGING NOT. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). ONSITE AT MAIN CAMPUS REVIEWING POSSIBLE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380388 ↗
• MalfunctionMay 17, 2024

  BRACCO FAST LOAD CTA DUAL SYRINGE- PROCEDURE: CT, UPON OPENING A NEW PACKAGE, THE SYRINGE PORTION OF THE DEVICE WAS INTACT AND NORMAL. THE "CURLY TUBING FOR FLUIDS" WAS MISSING THE ADAPTER END FOR PATIENT. THE LUER LOCK WAS MISSING ON THE PATIENT END. 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 19339804 ↗
• MalfunctionMay 3, 2024

  PROCEDURE- CT IN RADIOLOGY. WHEN CT ALMOST COMPLETE, THERE WAS A LOUD NOISE AND THE BRACCO SYRINGE EXPLODED AND BROKE IN HALF AT THE POINT OF HIGH INJECTION RATE. UNKNOWN HARM TO PATIENT. ENOUGH CONTRAST INJECTED TO FINISH SCAN. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: Insufficient Information

  MAUDE report 19237571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933846. One submission often covers many models, so check the product and lot details in each record.

• Z-0654-2019 · Nov 12, 2018 · Terminated
  Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and EmpowerCTA+ Injector Systems SKU 017344/6720 Empower FastLoad" CT S