Safari2 H74939661S1Recalls & reported problems
Lake Region Medical · Class 2
All models of SAFARI2 (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816349012587), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Entrapment of Device; Entrapment of Device
ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR: QUESTION: IT WAS REPORTED FROM THE USER FACILITY THAT THE SAFARI2 WAS EXCHANGED FOR A NEW GUIDEWIRE. YOU NOTED THAT THEY COULD NOT PERFORM THE PROCEDURE DUE TO THE SAFARI2 BEING STUCK. CAN YOU CLARIFY, WAS THE TAVR PROCEDURE ABORTED DUE TO THIS ISSUE WITH THE SAFARI2? OR WAS THE SAFARI2 EXCHANGED FOR ANOTHER GUIDEWIRE TO COMPLETE THE TAVR PROCEDURE? ANSWER: THE SAFARI WAS EXCHANGED FOR ANOTHER WIRE. QUESTION: DID THIS EVENT OCCUR DURING INSERTION, ADVANCING, OR WITHDRAWAL? ANSWER: ADVANCING. QUESTION: WHERE WAS THE WIRE WHEN IT HAD TO BE RETRACTED? ANSWER: IN THE AORTA. QUESTION: WHAT IS MEANT BY LOOKED PEEL? WAS THERE DAMAGE TO THE LUBRIGREEN¿ PTFE COATING? ANSWER: YES. QUESTION: WAS THERE FRACTURE/SHEAR DAMAGE TO THE COIL AND/OR CORE WIRE MATERIAL? ANSWER: YES. QUESTION: IS THIS A NEW OR EXPERIENCED USER? ANSWER: EXPERIENCED. I RECEIVED INFORMATION REGARDING THE STATE OF THE DEVICE WHEN IT WAS RECEIVED (IN 2 SEGMENTS). OUR FIELD REPRESENTATIVE REPLIED: I BELIEVE IT WAS CUT AFTER IT WAS REMOVED, AS THE PHYSICIAN TESTED THE DEVICE A LITTLE BIT AND NOTED IT WAS SEVERELY DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610558 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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