HYBRID Guidewire HYBRID1214DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053022784), received between May 28, 2021 and Jul 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT: "THE PHYSICIAN WAS SELECTING A DISTAL VESSEL OFF THE ECA WITH THE HYBRID WIRE, UPON PULLING THE WIRE BACK INTO THE MICRO IN ORDER TO SHOOT A CONTRAST INJECTION, IT APPEARED THE TIP OF THE HYBRID HAD BROKE OFF. THE ENTIRE MICRO-CATHETER HAD TO BE REMOVED IN ORDER TO GET THE WIRE OUT. ONCE COMPLETELY OUT OF THE BODY, THE SUSPICISION THAT THE WIRE HAD BROKE WAS CORRECT. THE WIRE IS AVAILABLE FOR RETURN." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589051 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED THAT: "RIGHT MCA ANEURYSM AND A RIGHT M2 BIFURCATION ANEURYSM TO BE TREATED DISTAL PORTION FIRST AND THAN PROXIMAL ANEURYSM. RADIAL ACCESS WITH NEW IMPERATIVE CARE GUIDE CATHETER THAT WAS KINKED GOING UP THE MCA. A PHEONOM PLUS WAS USED INSIDE GUIDE AND .035 WIRE TO FIX KINK. AFTER SEVERAL ATTEMPTS THE ISSUE COULD NOT BE RESOLVED AND THE PHYSICIAN DID AN EXCHANGE AND PUT IN A SHEATH WITH A WRIST CATHETER AND PHENOM PLUS INSIDE. ONCE DISTAL MCA WAS ACCESSED THE PHYSICIAN WENT UP WITH AN SL-10 AND A HYBRID 1214 WIRE TO ACCESS DISTAL ANEURYSM. THE ANATOMY WAS VERY TORTUOUS AND IT WAS DIFFICULT TO GET DISTAL AND THE PHSYCIAN SAID THE 1214 HYRBID WIRE BROKE AS HE PULLED IT OUT. THE WIRE WAS SEVERED AND HE USED A TRAXCESS 14 TO FINISH THE CASE AND TREAT THE ANEURYSMS." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066315 ↗
• MalfunctionMay 28, 2021Break; Failure to Advance; Break; Failure to Advance

  REPORT SENT TO FDA BY USER FACILITY: "DURING THE FIRST MANOEUVRE TO RAISE THE BALLOON (ECLIPSE 6X12), TO POSITION IT IN FRONT OF THE DECK OF THE ANEVRYSM (MANOEUVRING THAT WERE QUESTION) WE NOTICED THAT THE GUIDE DIT NOT RESPOND, NEITHER WITH TORQUE NOR WHILE WITH DRAWING IT. DUE TO THE ABOVE, WE DECIDED TO REMOVE THE BALLOON FROM THE PATIENT. ONCE OUTSIDE, WE COULD SEE THAT THE GUIDE WAS BROKE, PROBABLY DUE/ ON A TRANSITION ZONE, AND HAD DIVIDED IN TWO FRAGMENTS. AFTER THIS INCIDENT, WE HAND ANOTHER GUIDE WITH THE SAME BALLOON-CATHETER AND THE "... TECHNIQUE" COULD BE DONE WITHOUT ANY PROBLEM, WITH THIS NEW GUIDE." TO FULLY INVESTIGATE THIS CASE, COULD YOU RESPOND AT THE FOLLOWING QUESTIONS: -COULD YOU PLEASE CHECK THE INCIDENT DESCRIPTION THAT WE RECORD ON THE DOC ENCLOSED AND CORRECT THIS IF NECESSARY? (IT WAS DIFFICULT TO ME TO BE SURE TO UNDERSTAND THE INFORMATION OF THE INCIDENT FORM) CORRECT -COULD YOU PLEASE SEND US THE NAME OF THE HOSPITAL AFFECTED BY THIS INCIDENT? (B)(6). -COULD YOU PLEASE TELL ME WHEN THE AFFECTED PRODUCT WILL SENT TO BALT EXTRUSION? IT HAS BEEN SENT ALREADY TO BALT EXTRUSION -COULD YOU PLEASE TELL ME WHAT IT THE CHARACTERISTIC OF THE PATIENT ANATOMY (T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904402 ↗