SAFARI2™ H74939706JPNS0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816349012327), received between Jun 7, 2021 and Aug 19, 2025 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 reports).

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT: THE DEVICE WAS UNABLE TO CROSS. THE WIRE GOT STUCK INSIDE THE TAVI SYSTEM, SO IT WAS REPLACED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE?; NO. WHERE IT WAS UNABLE TO CROSS? (LESION, SHEATH, INSIDE GUIDING CATHETER, ETC.,); SHEATH. SHAPING; NO. RESOLUTION: DIFFERENT DEVICE USED (SAME MODEL). WHERE DID EVENT OCCUR: INSIDE THE PATIENT. WHERE DID EVENT OCCUR: NO PATIENT INJURY. TESTED PRIOR TO USE: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843291 ↗
• DeathAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: A TRANSCATHETER AORTIC VALVE IMPLANTATION WAS PERFORMED AND A 25 MM NAVITOR TRANSCATHETER BIOPROSTHETIC VALVE SYSTEM WAS ATTEMPTED. DURING THE IMPLANTATION OF THE NAVITOR, THE BLOOD PRESSURE DECREASED AND AN ECHOCARDIOGRAM WAS PERFORMED, WHICH REVEALED A PERICARDIAL EFFUSION. THE PHYSICIAN DETERMINED THAT THE USE OF THE SAFARI GUIDEWIRE HAD CAUSED LEFT VENTRICULAR PERFORATION, LEADING TO CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS PERFORMED, AND THE PATIENT IMMEDIATELY UNDERWENT OPEN-CHEST SURGERY. HEMOSTASIS WAS ATTEMPTED AT THE PERFORATION SITE BY SUTURING, BUT AS THIS WAS NOT ACHIEVED, LEFT VENTRICULAR RECONSTRUCTION WAS PERFORMED. HOWEVER, AS THE BLEEDING WAS STILL NOT COMPLETELY STOPPED, THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT (ICU) WITH SOME DEGREE OF HEMOSTASIS ACHIEVED. ON (B)(6) 2024, THE PATIENT DIED. REGARDING THE CAUSE OF DEATH, THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS HEMORRHAGE DUE TO PERFORATION OF THE LEFT VENTRICULAR APEX BY A GUIDEWIRE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 19933575 ↗
• MalfunctionJun 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT: DEVICE WAS DAMAGED. WAS THERE ANY VISIBLE ISSUE BEFORE USAGE? NO. WHICH LOCATION AND WHAT KIND OF DAMAGE WAS FOUND? IT WAS FOUND TO BE SEPARATED DURING INSERTION, SO THE USAGE WAS STOPPED. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608714 ↗
• MalfunctionFeb 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE TIP PART OF THE COIL GOT STUCK AND HAS BEEN STRETCHED. ADDITIONAL INFORMATION: THIS ISSUE OCCURRED AT THE BEGINNING OF THE PROCEDURE. SAFARI WAS USED AT THE TIME OF WIRE CHANGE AFTER INSERTING RADIFOCUS AND 5F PIG FROM THE INTRODUCER SHEATH. AT THIS POINT, THE DOCTOR FELT SOMETHING WAS WRONG, SO WHEN SAFARI WAS PULLED OUT, THE TIP WAS FOUND TO BE STRETCHED. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18801698 ↗
• MalfunctionJan 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: EVENT; SHAPING; NO THE COATING WAS PEELED OFF, AND THE DEVICE WAS DIFFICULT TO CROSS; THEREFORE, IT WAS REPLACED. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 24DEC2023: THE ISSUE OCCURRED AT OUTSIDE BODY DURING PREPARATION. WHEN THE DEVICE WAS UNPACKING, THE PHYSICIAN VISUALLY CONFIRMS THAT THE COATING ON THE WIRE ON THE OPPOSITE SIDE OF THE PART TO BE INSERTED INTO THE PATIENT HAS PEELED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425905 ↗
• MalfunctionDec 18, 2023Entrapment of Device; Entrapment of Device

  THE WIRE AND BALLOON GOT STUCK AND COULD NOT BE REMOVED. EVENTUALLY THEY WERE PULLED OUT TOGETHER. THEY WERE EVENTUALLY REMOVED TOGETHER. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346621 ↗
• MalfunctionJun 7, 2021Entrapment of Device; Entrapment of Device

  THIS DEVICE WAS DELIVERED, AND AN ELOLUTE R WAS PLACED. THERE WAS A RESISTANCE WHEN THE DEVICE WAS REMOVED, AND IT COULD NOT BE REMOVED AT FIRST. A JR IMAGING CATHETER WAS INSERTED, AND THIS DEVICE WAS SUCCESSFULLY REMOVED. WHEN THE DEVICE WAS CONFIRMED OUTSIDE THE BODY, A TISSUE WAS ATTACHED AT THE COIL PART OF THE TIP. WHEN A PATHOLOGICAL ANALYSIS WAS PERFORMED, IT WAS REPORTED THAT IT WAS A PART OF THE CHORDAE TENDINEAE AND MITRAL VALVE. PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND SUCH (AN ISSUE OCCURRED, BUT TARGET TREATMENT WAS COMPLETED.) THERE WAS NO REPORT OF SERIOUS INJURY AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946959 ↗