FastLoad™ CTA Dual Syringe Pack with Spikes 017355Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 17630039300873), received between Apr 25, 2018 and Jan 30, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Burst Container or Vessel; Nonstandard Device; Fail-Safe Problem

  FASTLOAD CT SYRINGE EXPLODED WHILE PERFORMING INJECTION. NO PATIENT INJURY OR HARM. AFTER EVALUATING THE LOT NUMBER, IT WAS DETERMINED THAT THIS LOT # OF SYRINGE WAS RECALLED IN DECEMBER. WE WENT THROUGH THE DEPARTMENT AND 48 CASE PLUS 300 IN THE DEPARTMENT WERE RECALLED. BRACCO HAD SENT FACILITY PRODUCTS THAT WERE RECALLED ALREADY. BOXES WITH LOT #261714 WAS RECEIVED BY OUR FACILITY JANUARY 2025. THE SYRINGE USED ON THIS PATIENT WAS PULLED FROM THIS BOX FILLED WITH THE RECALLED LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277205 ↗
• MalfunctionFeb 20, 2024

  WHILE WORKING IN THE CT DEPARTMENT, STAFF NOTICED THE CT POWER INJECTOR SYRINGE HAD A BROKEN PIECE UPON OPENING PACKAGE. SHE DID NOT LOAD INTO INJECTOR AND SYRINGE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739155 ↗
• MalfunctionFeb 20, 2024

  A BRACCO CT FASTLOAD SYRINGE WAS NOTICED TO HAVE BROKEN PIECES IN PACKAGE UPON OPENING. TECH NOTICED WHITE PIECES FROM SYRINGE IN PACKAGING AND DID NOT USE SYRINGE. ALL PARTS AND PACKAGING SAVED. LOT#244589. EXPIRATION 2026-10-10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18737796 ↗
• MalfunctionJan 24, 2024

  BRACCO CT POWER INJECTOR SYRINGE FAILED DURING INJECTION FOR CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) EXAM. AS PER NORMAL PRACTICE THE SYRINGE WAS VISUALLY CHECKED PRIOR TO INSERTING INTO THE POWER INJECTOR. NO FLAWS WERE DETECTED AT THIS TIME AND THE CT TECH HAD NO ISSUES ATTACHING AND FILLING SYRINGES. DURING INJECTION OF ISOVUE 370 FOR BOLUS TRACKER AT 5.5CC/SEC, A LOUD POP WAS HEARD. THE CT TECH, STOPPED THE INJECTION IMMEDIATELY AND WENT IN ROOM TO CHECK ON PATIENT. THERE WAS NO HARM TO PATIENT. THE TECH THEN NOTICED THE BROKEN SYRINGE HANGING BY THE ATTACHED TUBING. NEW SYRINGE WAS OPENED AND USED TO COMPLETE EXAM. EXAM COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570062 ↗
• MalfunctionDec 5, 2023

  THE PATIENT WAS BEING INJECTED THROUGH A POWERPORT AND THE CONTRAST SYRINGE BROKE AND POPPED OFF THE POWER INJECTOR. PLASTIC PIECES DISPERSED BUT A CURTAIN BARRIER WAS USED AND THE PATIENT WAS NOT HARMED. INJECTOR SYRINGES WERE REPLACED AND TEST SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266142 ↗
• MalfunctionDec 5, 2023

  A FASTLLOAD CTA DUAL SYRINGE PACK, FROM LOT 241679, WAS PLACED ON THE INJECTOR HEAD AND THE CONTRAST AND SALINE LOADING PROCESS WAS INITIATED. THE CT TECH WALKED AWAY TO PLACE A SHEET ON THE EXAM TABLE AND TO DISTANCE MYSELF FROM THE HEAD UNIT. NO AUDIBLE NOISE WAS MADE , BUT WHEN THE CT TECH STEPPED BACK TO THE INJECTOR HE NOTICED THE BLACK AND WHITE PLUNGER ON THE CONTRAST SIDE WAS STUCK AT THE TOP OF THE SYRINGE AND SOME WHITE PLASTIC WAS MISSING.

  Patient problems: Insufficient Information

  MAUDE report 18265654 ↗
• MalfunctionNov 21, 2023

  TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) CT PERFORMED 85ML ISOVUE 370 INJECTED 65ML OF SALINE DID NOT FOLLOW INJECTION AS REQUIRED, INJECTOR FAILED TO INJECT SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182034 ↗
• MalfunctionNov 20, 2023

  DURING CONTRAST INJECTION, THE SYRINGE ON THE CONTRAST SIDE WAS SHEARED OFF AT THE BOTTOM OF INJECTOR AND SCAN HAD TO BE ABORTED. THE INJECTOR WAS RELOADED AND PATIENT WAS SCANNED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169220 ↗
• MalfunctionNov 8, 2023

  WHILE INJECTING A PATIENT WITH IV CONTRAST, THE BRACCO INJECTOR SYRINGE BROKE COMPLETELY FREE FROM THE HEAD UNIT AND THE PLUNGER SEPARATED THE SYRINGE CYLINDER FROM THE LOCKING DISC AT THE BASE. THIS FAILURE SENT THE SYRINGE HURTLING TOWARD THE PATIENT LIKE A PROJECTILE. THE ATTACHED EXTENSION TUBING PREVENTED IT FROM STRIKING THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091967 ↗
• MalfunctionNov 8, 2023

  WHILE INJECTING IV CONTRAST VIA BRACCO INJECTOR, THE FASTLOAD CTA INJECTOR SYRINGE EXPLODED. PATIENT'S FACE WAS ALMOST HIT BY SHARP PIECE OF SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091916 ↗
• MalfunctionNov 8, 2023

  PATIENT HAD A 20G PERIPHERAL IV FLUSHED WELL PRIOR TO CONTRAST. J LOOP WAS STRAIGHT WITHOUT RESISTANCE ON HAND FLUSH. WHEN TECH ATTEMPTED TO INJECT CONTRAST, TWO LOUD CLICKS WERE HEARD FOLLOWED BY PSI ON MONITOR SHOOTING UP TO 300 PSI. INJECTION WAS IMMEDIATELY HALTED BEFORE SYRINGE HAD A CHANCE TO EJECT OFF THE INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091879 ↗
• MalfunctionOct 3, 2023

  BRACCO INJECTOR SYRINGE EXPLODED AFTER SPIKE GOT STUCK INTO THE SYRINGE. THE SALINE WAS BEING LOWERED TO REPLACE AND THE TOP/BEVELED END OF THE SYRINGE BROKE OFF AND SHOT ACROSS THE ROOM. THE EXPLODED SYRINGE HIT THE EMPLOYEE IN THE BACK. NO INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860129 ↗
• MalfunctionJun 9, 2023Component Missing

  REPORTED FASTLOAD CTA DUAL SYRINGES ONLY HAD ONE SPIKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097319 ↗
• MalfunctionJun 9, 2023Component Missing

  NOTED NO SPIKES IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097313 ↗
• MalfunctionJun 9, 2023Component Missing

  OPENED PACKAGE NOTED SPIKE MISSING. THIS DEVICE WAS NOT USED ON ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097268 ↗
• MalfunctionJun 8, 2023Contamination; Particulates

  NOT USED ON PATIENT - NOTED BROKEN TEETH ON SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086038 ↗
• MalfunctionMar 15, 2023Noise, Audible; Explosion

  FASTLOAD CTA POWER INJECTOR SYRINGE WAS LOADED INTO THE INJECTOR. THE CT TECH BEGAN THE INJECTION AND ALMOST IMMEDIATELY, A VERY LOUD POP WENT OFF ALARMING THE PATIENT AND TECH. THE INJECTOR SYRINGE FILLED WITH CONTRAST EXPLODED OFF THE INJECTOR AND FLEW DIRECTLY TOWARDS THE PATIENT. THE BASE OF THE CONTRAST SYRINGE RING COMPLETELY SEVERED FROM THE MAIN PORTION OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544930 ↗
• MalfunctionJul 5, 2018No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2018, A HEALTHCARE PROFESSIONAL (NURSE) REPORTED TO BRACCO INJENEERING A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CTA SYRINGE PACK. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 25-JUN-2018. THE NURSE REPORTED WHEN ATTEMPTING TO LOAD, THE FASTLOAD CTA CT SYRINGE PACK ON THE INJECTOR, THE DUAL FILL BUTTON ON THE TOUCH SCREEN WAS PRESSED AND AN ERROR MESSAGE WAS RECEIVED: SYSTEM FAULT N°234 - AN INJECTOR HARDWARE FAULT WAS DETECTED - RE-POWER INJECTOR OR CALL FOR SERVICE. AFTER 3 UNSUCCESSFUL RESTARTS, A DIFFERENT SCANNER WAS USED FOR THE STUDY. THE OPERATOR ATTEMPTED A FEW MORE RESTARTS AND TRIED TO REMOVE THE SYRINGE IN THE INJECTOR. A PUDDLE OF WATER WAS NOTED ON THE FLOOR AT THIS TIME. WHEN HE INVERTED THE HEAD OF THE INJECTOR, WATER POURED OUT OF THE HEAD OF THE INJECTOR, SO IT WAS SHUT DOWN FOR SAFETY. THE CAUSE OF POURING WAS IDENTIFIED AS THE SPIKE USED TO LOAD SALINE INTO ONE OF THE SYRINGES, BECAUSE IT CRACKED WHEN TWISTED ON THE SYRINGE. DEFECTIVE KITS WERE RETURNED TO BRACCO INJENEERING FOR INVESTIGATION. NO PATIENT OR OPERATOR INJURY WAS REPORTED. A QUALITY INVESTIGATION IS ONGOING. (B)(4). CORRESPONDING WORLDWIDE CASE ID: (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7665113 ↗
• InjuryApr 25, 2018Device Displays Incorrect Message

  WHEN ATTEMPTING TO LOAD THE FASTLOAD CTA CT SYRINGE PACK ON THE INJECTOR, A 100ML IV SALINE BAG WAS ATTACHED TO THE PROVIDED SPIKE TO PIERCE THE BAG. AFTER ATTACHING IT TO THE SYRINGE, I PLACED THE CONTRAST ON THE OTHER PROVIDED SPIKE AND BEGAN TO DRAW THE FLUIDS INTO THE SYRINGES. WHEN THE "DUAL FILL" BUTTON WAS PRESSED ON THE TOUCH SCREEN I RECEIVED AN ERROR: SYSTEM FAULT NO. 234 - AN INJECTOR HARDWARE FAULT WAS DETECTED - RE-POWER INJECTOR OR CALL FOR SERVICE. I ATTEMPTED TO RESTART THE INJECTOR 3 TIMES. BECAUSE A PATIENT WAS WAITING, A DIFFERENT SCANNER WAS USED FOR THE STUDY. ONCE RETURNING TO THE PROBLEM INJECTOR, I ATTEMPTED A FEW MORE RESTARTS AND TRIED TO REMOVE THE SYRINGES IN THE INJECTOR. A PUDDLE OF WATER WAS NOTED TO BE ON THE FLOOR AT THIS TIME. WHEN I INVERTED THE HEAD OF THE INJECTOR (AS I WOULD FOR ANY EXAM) WATER BEGAN POURING OUT OF THE HEAD OF THE INJECTOR. UPON REALIZING THIS, THE INJECTOR WAS SHUT OFF FOR SAFETY. THERE IS A SPIKE THAT IS USED TO LOAD SALINE INTO ONE OF THE SYRINGES, WHEN THE SPIKE IS TWISTED ONTO THE SYRINGE IT CRACKS THE SPIKE. THEN IT LETS THE SALINE RUN DOWN INTO THE INJECTOR. WHICH CAUSES THE INJECTOR TO MALFUNCTION. THERE IS A SPIKE THAT

  Patient problems: No Information

  MAUDE report 7464717 ↗

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