SAFARI™ H74939272S0Recalls & reported problems
Lake Region Medical · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729846048), received between Mar 30, 2022 and Mar 30, 2022 — classified as 1 death.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Malposition of Device1
Patient problems
- Cardiac Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 30, 2022Malposition of Device; Deformation Due to Compressive Stress; Malposition of Device; Deformation Due to Compressive Stress
DURING A ROUTINE TAVI PROCEDURE-IDE STUDY PATIENT. THE SAFARI SMALL WIRE WAS CANNULATED WITH A PIG TAIL IN THE NORMAL FASHION. IT WAS NOTED TO HAVE A FUNNY SHAPE AND IMPLANTED DEEP INTO THE VENTRICLE. THE IMPLANTER WAS GOING TO REPOSITION BUT THE PATIENTS BLOOD PRESSURE DROPPED AND WENT INTO FULL CARDIAC ARREST. ON TTE THERE INDICATED A VERY LARGE CARDIAC TAMPONADE AND THE TEAM DECIDED TO OPEN THE CHEST AND PUT THE PATIENT ON BYPASS TO REPAIR THE LV TEAR. ALL WIRES AND SHEATHS WERE REMOVED FROM THE HEART AND ISLEEVE REMAINED INTACT IN THE LEFT FEMORAL ARTERY FOR POTENTIAL TAVI. THE TEAR WAS ON THE LATERAL SIDE OF THE LEFT VENTRICLE - A STRAIGHT LINE ABOUT 3CM IN LENGTH. THIS WAS REPAIRED WITH SUCCESS AND THE TAVI PROCEDURE CONTINUED AS PLANNED ON BYPASS. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: THE WIRE APPEARED TO BE COMPRESSED AND BENDING ON LATERAL SIDE OF VENTRICLE. REPOSITION WAS GOING TO BE ATTEMPTED BUT THE PATIENTS BLOOD PRESSURE PLUMMETED AND WENT INTO CARDIAC ARREST. WHAT IS THE NEXT COURSE OF ACTION?: CPR, ECHO SHOWING PERICARDIAL EFFUSION, OPEN HEART SURGERY TO REPAIR THE TEAR THAT WAS LOCATED AND CONTINUE WITH TAVI
Patient problems: Cardiac Perforation
MAUDE report 13953613 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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