MEDRAD® MRXperion MR Injection SystemRecalls & reported problems
Bayer Medical Care Inc. · SYSTEM,INJECTOR,MRXPERION (86410036) · 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 00616258021355), received between Dec 8, 2023 and Dec 8, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (K143538); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Physical Resistance/Sticking1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2023Insufficient Device Problem Information; Physical Resistance/Sticking; Insufficient Device Problem Information; Physical Resistance/Sticking
BAYER RADIOLOGY WAS NOTIFIED OF AN INJURY THAT OCCURRED TO A TECHNOLOGIST WHILE A MEDRAD® MRXPERION INJECTION SYSTEM (SERIAL NUMBER (B)(6)) WAS IN USE. THE CUSTOMER REPORTED THAT, AS THE TECHNOLOGIST WAS MOVING THE INJECTOR AFTER COMPLETING A PROCEDURE, THE WHEELS BECAME "STUCK," AND THE INJECTOR LIFTED OFF OF THE FLOOR. AS THE TECHNOLOGIST WAS ATTEMPTING TO STEADY THE INJECTOR BACK ONTO THE FLOOR, THE INJECTOR LANDED ON TOP OF HER FOOT (SIDE UNKNOWN). THE TECHNOLOGIST WAS REFERRED TO URGENT CARE AT WHICH TIME AN X-RAY CONFIRMED A FRACTURED FIFTH DIGIT (TOE). THE TECHNOLOGIST HAS RETURNED TO WORK WITH NO FURTHER ISSUES REPORTED.
Patient problems: Bone Fracture(s)
MAUDE report 18291927 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143538. One submission often covers many models, so check the product and lot details in each record.
- Z-2244-2016 · Jun 9, 2016 · TerminatedAngiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe b
Other Injector And Syringe, Angiographic devices
- Monarch® 00884450298022Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls37 reports
- Monarch® 00884450298060Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- Blue Diamond™ 00884450498743Merit Medical Systems, Inc. · Injector and syringe, angiographic2 recalls0 reports
- Monarch® 00884450298053Merit 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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