FastLoad™ CTA Dual Syringe Pack with spikes 017347Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17630039300330), received between May 30, 2017 and May 30, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2017Material Integrity Problem; Material Integrity Problem

  ON 01-MAY-2017, A HEALTHCARE PROFESSIONAL REPORTED TO BRACCO INJENEERING (BINJ) A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CTA DUAL SYRINGE PACK WITH SPIKES. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON (B)(6) 2017. ON 26-APR-2017, DURING A CT INJECTION, 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: 02-JUL-2018: BINJ RECEIVED FOLLOW-UP INFORMATION WHICH WAS SENT TO BRACCO ON (B)(6) 2018. DETAILED DESCRIPTION OF THE DEVICE MALFUNCTION WAS ADDED TO THE CASE. THIS CASE IS MEDICALLY CLOSED. FDA#: 3004753774-2017-00004. BRACCO WORLDWIDE CASE ID#: US-BRACCO-2017US06126 (PREVIOUSLY REPORTED AS US-BRACCO-000120-MD). COMPANY COMMENT: BASED ON TWO DECADES OF EXPERIENCE WITH THE EMPOWER INJECTOR, IT IS THE OPINION OF BRACCO MEDICAL ADVISORY BOARD MEMBER THAT THE LIKELIHOOD OF A SYRINGE BURST IS VERY SMALL AND IF ONE SHOULD OCCUR, THE LIKELIHOOD OF SERIOUS HARM OR PERMANENT INJURY OR DISABILITY TO PATIENTS OR HEALTHCARE PERSONNEL IS EXTREMELY LOW WHEN COMPARED TO THE TOTAL OF DEVICES SOLD ON THE MARKET (2 PPM).

  Patient problems: No Patient Involvement

  MAUDE report 6598764 ↗

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