SAFARI2™ Extra Support H74939597ESXS1Recalls & reported problems
Lake Region Medical · Class 2
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 00816349012624), received between Nov 30, 2023 and Nov 30, 2023 — 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 30, 2023Entrapment of Device; Entrapment of Device
EVENT DESCRIPTION: AS PER MD, THE NAVITOR VALVE/DELIVERY SYSTEM WAS 'STUCK' ON THE SAFARI EXTRA SUPPORT WIRE AND COULD NOT ADVANCE. THE WIRE AND VALVE/DS WERE REMOVED AS A UNIT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: N/A. WHAT IS THE NEXT COURSE OF ACTION?: N/A. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: ADDITIONAL INTERVENTION REQUIRED. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: YES. PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION?: THE TAVR VALVE AND DELIVERY SYSTEM WOULDN'T ADVANCE ON THE WIRE MEDICAL OR SURGICAL INTERVENTIONS: UNKNOWN. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN. PATIENT OUTCOME: UNKNOWN. THE FOLLOWING INFORMATION WAS RECEIVED REGARDING THIS EVENT ON 13NOV2023: QUESTION: WAS THERE ANY DAMAGE NOTED TO THE SAFARI2 ES GUIDEWIRE PRIOR TO USE? ANSWER: NO. QUESTION: WAS THE CURVE OF THE SAFARI2 ES GUIDEWIRE CONSTRAINED WITHIN A CATHETER DURING INSERTION INTO THE BODY OR TREATMENT SITE? ANSWER: UNKNOWN. QUESTION: WAS THERE ANY RESISTANCE NOTED DURING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18236997 ↗
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- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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