Hornet™ 14 H749393071900Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729887751), received between Dec 12, 2018 and Sep 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING AN ATTEMPT TO ADVANCE A 190CM STRAIGHT TIP, HORNET 14 GUIDEWIRE THROUGH A CHRONIC TOTAL OCCLUSION IN THE CORONARY ARTERY, THE DISTAL TIP OF THE WIRE FRACTURED AND REMAINED WITHIN THE VESSEL. THE FRAGMENT WAS SUBSEQUENTLY EMBEDDED BY THE DEPLOYED STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23137462 ↗
• InjuryNov 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED AND WAS UNRETRIEVED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH A CHRONIC TOTAL OCCLUSION (CTO) OF THE CIRCUMFLEX ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 190CM STRAIGHT TIP POUCH HORNET 14 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE WIRE TIP BECAME STUCK IN THE CALCIFIED LESION AND WITH FURTHER MANIPULATION, THE TIP OF THE WIRE BROKE OFF AND REMAINED IN THE PATIENT. THE REST OF THE WIRE WAS REMOVED SUCCESSFULLY. THE DECISION WAS MADE TO NOT RETRIEVE THE DETACHED GUIDEWIRE TO PREVENT FURTHER INJURY. THE INTENDED STENT WAS PLACED AND ADDITIONALLY STABILIZED THE WIRE TIP FRAGMENT TO THE VESSEL WALL WITH STENT PLACEMENT. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18221906 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED WHICH LED TO PERICARDIAL EFFUSION REQUIRING ADDITIONAL INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM STRAIGHT TIP HORNET 14 GUIDEWIRE WAS ATTEMPTED TO CROSS THE LESION. THE 190CM STRAIGHT TIP HORNET 14 GUIDEWIRE THEN PERFORATED THE VESSEL. PERICARDIAL EFFUSION WAS OBSERVED AND WAS TREATED WITH PERICARDIOCENTESIS. THE PROCEDURE WAS ABORTED DUE TO THE PERFORATION AND IT IS PLANNED TO RESCHEDULE THE TREATMENT FOR A LATER DATE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 11255362 ↗
• InjuryDec 12, 2018Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM STRAIGHT TIP HORNET 14 GUIDEWIRE WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE TIP GOT FRACTURED. NO FRAGMENT WAS LEFT INSIDE THE PATIENT'S BODY. A SPRING COIL BROUGHT THE REMAINING PORTION OF THE WIRE BACK TOGETHER. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156534 ↗