MEDRAD® MRXperion MR Injection System MRXP 200Recalls & reported problems
Bayer Medical Care Inc. · SYSTEM,INJECTOR,MRXPERION,CORE,LR (87838420) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00616258025094), received between Jun 17, 2025 and Jan 6, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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, 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Unintended Electrical Shock1
- Unintended Movement1
- Unintended System Motion1
Patient problems
- Electric Shock1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Insufficient Device Problem Information; Unintended Electrical Shock
THE CUSTOMER REPORTED THE FOLLOWING: WHILE PERFORMING A SIGNAL TO NOISE RATIO (SNR) TEST ON THE MEDRAD® MRXPERION INJECTION SYSTEM (SERIAL NUMBER (B)(6), THE TECHNOLOGIST OBSERVED THAT THE SNR RESULT WAS LOWER THAN EXPECTED. PRIOR TO REPEATING THE TEST, THE EMPLOYEE UNPLUGGED THE ENERGIZED POWER SUPPLY FROM THE WALL OUTLET AND EXPERIENCED AN ELECTRICAL SHOCK SENSATION. IN ACCORDANCE WITH HOSPITAL PROTOCOL, THE EMPLOYEE WAS EVALUATED IN THE EMERGENCY ROOM AND WAS SUBSEQUENTLY DISCHARGED. THE SITE HAS CONFIRMED THAT THE TECHNOLOGIST HAS SINCE RETURNED TO FULL DUTY WITH NO FURTHER ISSUES REPORTED.
Patient problems: Electric Shock
MAUDE report 23975385 ↗MalfunctionJun 17, 2025Unintended System Motion; Unintended Movement; Insufficient Device Problem Information; Unintended System Motion; Unintended Movement; Insufficient Device Problem Information
A BAYER SERVICE REPRESENTATIVE WAS ONSITE TO INSTALL A NEW MEDRAD® MRXPERION INJECTION SYSTEM IN A NEW MRI SUITE. A SCREWDRIVER THAT THE REPRESENTATIVE WAS USING WAS PULLED INTO THE CANON MAGNET BORE. THE TOOL WAS ABLE TO BE REMOVED WITHOUT HAVING TO RAMP DOWN THE MAGNET. NO INJURY OR ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22227019 ↗
Other Injector And Syringe, Angiographic devices
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- 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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