EmpowerCTA®+ Injector System 017285 (UDI 47630039300430)Recalls & reported problems
Bracco Injeneering SA · Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300488 1 x Injector GTIN : 37630039300747 · Class 2
Data updated Oct 16, 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 47630039300430), received between Jul 24, 2019 and Jul 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software Problem” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Computer Software Problem1
Patient problems
- Distress1
- Extravasation1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2019Computer Software Problem; Adverse Event Without Identified Device or Use Problem; Computer Software Problem; Adverse Event Without Identified Device or Use Problem
THE INJECTOR HAD INJECTED ON ITS OWN WHEN OPERATOR WASN'T WATCHING. PATIENT SAID HER ARM WAS BURNING. TECH SAID 70-80ML'S WAS INJECTED. PATIENT SUFFERED PAIN AND DISTRESS.
Patient problems: Distress; Extravasation; Pain
MAUDE report 8824007 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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