FastLoad CTA Dual Syringe Pack with SpikesRecalls & reported problems across all models
Bracco Injeneering SA · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of FastLoad CTA Dual Syringe Pack with Spikes by Bracco Injeneering SA in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between May 30, 2017 and Jan 30, 2025 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Component Missing” (3 reports).
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 with Spikes problems
Device problems
- Component Missing3
- Burst Container or Vessel1
- Contamination1
- Device Displays Incorrect Message1
- Explosion1
- Fail-Safe Problem1
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Patient Involvement2
- Insufficient Information1
- No Information1
FastLoad CTA Dual Syringe Pack with Spikes models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FastLoad™ CTA Dual Syringe Pack with Spikes 017355Injector And Syringe, Angiographic19 reports
- FastLoad™ CTA Dual Syringe Pack with spikes 017347Injector And Syringe, Angiographic1 report
Recent FastLoad CTA Dual Syringe Pack with Spikes adverse event reports
The 15 most recent reports across all models, 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 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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