Marinr™ 043325MRecalls & reported problems
Medtronic, Inc. · CATH 043325M MARINR CS W/O CE · 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 00763000227852), received between Oct 11, 2022 and Oct 11, 2022 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS DIFFICULT TO ENGAGE THE CORONARY SINUS WITH AN UNKNOWN MANUFACTURER'S GUIDEWIRE. THE GUIDEWIRE WAS REPLACED WITH A MEDTRONIC DIAGNOSTIC CATHETER. WHEN THE DIAGNOSTIC CATHETER WAS ADVANCED AND FELT TO ENGAGE THE CORONARY SINUS, CONTRAST WAS INJECTED AND APPEARED TO BE FLOWING FREELY INTO THE PERICARDIUM. CARDIAC PERFORATION OF THE CORONARY SINUS WAS SUSPECTED. THE PROCEDURE WAS PAUSED AND CLOSELY MONITORED. AFTER SEVERAL MINUTES, THERE WERE NOT ANY CHANGES IN VITAL SIGNS. THE PROCEDURE WAS CONTINUED AND COMPLETED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation of Vessels
MAUDE report 15579384 ↗
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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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