EmpowerMR® Injector System without Remote Control 017377Recalls & reported problems
Bracco Injeneering SA · Composed of: 1 x Hydraulic Controller 1 x Injector Head 1 x Electro-Hydraulic Interconnect · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 47630039300973), received between Jul 21, 2025 and Jul 21, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Extravasation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING AN MRI USING THE EMPOWERMR INJECTION SYSTEM TO ADMINISTER CONTRAST MEDIA, A PATIENT EXPERIENCED AN EXTRAVASATION OF CONTRAST MEDIA IN THE FOREARM, WITH PAIN AND EDEMA IN THE LOCAL SITE OF THE INJECTION. THE PATIENT WAS IMMEDIATELY TREATED WITH AN ICE COMPRESS. THE PATIENT REPORTED IMPROVEMENT ON (B)(6) 2025.
Patient problems: Extravasation
MAUDE report 22560872 ↗
Other Injector, Contrast Medium, Automatic devices
- MEDRAD® Stellant FLEX Syringe Kit FLEXD-150-SPKBayer Medical Care Inc. · Injector, Contrast Medium, Automatic1 recall0 reports
- MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc. · Injector, Contrast Medium, Automatic19 reports
- MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade)Bayer Medical Care Inc. · Injector, Contrast Medium, Automatic16 reports
- LF 844005Liebel-Flarsheim Company LLC · Injector, Contrast Medium, Automatic6 reports
- FastLoad™ MR Syringe Pack 017356Bracco Injeneering SA · Injector, Contrast Medium, Automatic4 reports
- EmpowerCTA®+ Injector System 017285Bracco Injeneering SA · Injector, Contrast Medium, Automatic2 deaths3 reports
- LF 844007Liebel-Flarsheim Company LLC · Injector, Contrast Medium, Automatic2 reports
- UL_INJECT XD 8000Ulrich GmbH & Co. KG · Injector, contrast medium, automatic1 death1 report
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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