FastLoad™ CTA Dual Syringe Pack 017346Recalls & reported problems
Bracco Injeneering SA · Class 2
All models of FastLoad CTA Dual Syringe Pack (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17630039300323), received between Jul 24, 2017 and Jul 24, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
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
Device problems
- Device Handling Problem1
- Material Integrity Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2017Material Integrity Problem; Device Handling Problem; Material Integrity Problem; Device Handling Problem
ON (B)(6) 2017, A HEALTHCARE PROFESSIONAL REPORTED TO BRACCO INJENEERING (BINJ) A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CTA DUAL SYRINGE PACK . THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON (B)(6) 2017. ON (B)(6) 2017, DURING A CT INJECTION SET UP, THE SYRINGE POPPED OUT OF THE CT INJECTOR. NO PATIENT OR USER/OPERATOR INJURY. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR. A QUALITY INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION IS REQUIRED.
Patient problems: No Patient Involvement
MAUDE report 6735277 ↗
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 · TerminatedEmpower 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
Other Injector And Syringe, Angiographic devices
- Monarch® 00884450298022Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls37 reports
- Blue Diamond™ 00884450498743Merit Medical Systems, Inc. · Injector and syringe, angiographic2 recalls0 reports
- Monarch® 00884450298053Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- Monarch® 00884450298060Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- NAMIC 80085007Medline Industries, Inc. · Injector and syringe, angiographic1 recall36 reports
- NA 622510B. Braun Medical Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC85 reports
- NAMIC 80087007Medline Industries, Inc. · Injector and syringe, angiographic1 recall20 reports
- Blue Diamond™ 00884450381168Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC1 recall6 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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