HYBRID Guidewire HYBRID1214DARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818053022791), received between Nov 22, 2023 and Oct 1, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT: "12/14 HYBRID WIRE WAS ATTEMPTED FOR DIFFICULT ANATOMY AT THE A2 TAKEOFF. THE DISTAL END OF WIRE SNAPPED OFF IN THE CATHETER SO THEY HAD TO REMOVE THE WIRE AND CATHETER. THE PORTION OF THE CATHETER IN WHICH THE WIRE SNAPPED OFF DID NOT SEEM TORTUOUS, THE PHYSICIAN WAS CONFUSED WHY IT WOULD BREAK AT THAT POINT. I HAVE THE WIRE TO RETURN, NOT THE CATHETER" INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345062 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT: "TIP OF WIRE BROKE OFF AND WAS NOT RETRIEVABLE". INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983162 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT: "ON (B)(6) DURING A PROSTATE ARTERY EMBOLIZATION A HYBRIB 1214DA GUIDE WIRE WAS INTRODUCED INTO A MICRO CATHETER. AS SOON AS THE PHYSICIAN PULLED THE WIRE BACK, HE SAYS THAT THE WIRE WAS STUCK AND BROKE. THEY HAD TO PULL THE WHOLE SYSTEM OUT AND START OVER ON THIS SIDE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890763 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT: "ON (B)(6) DURING A PROSTATE ARTERY EMBOLIZATION A HYBRIB 1214DA GUIDE WIRE WAS INTRODUCED INTO A PROWLER SELECT PLUS-J SHAPE MICRO CATHETER. AS SOON AS THE PHYSICIAN PULLED THE WIRE BACK, HE SAYS THAT THE WIRE WAS STUCK AND BROKE. THEY HAD TO PULL THE WHOLE SYSTEM OUT AND START OVER ON THIS SIDE. WHEN THEY MOVED ON TO TREAT THE OTHER SIDE, THEY USED A SWIFT NINJA STEERABLE MICRO CATHETER AND INTRODUCED A HYBRID 1214DA FOR THIS SIDE AS WELL, AND THE SAME THING HAPPENED. WHEN THEY PULLED THE WIRE BACK, THE WIRE WAS BROKEN." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721120 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT: "ON JAN. 17TH DURING A PROSTATE ARTERY EMBOLIZATION A HYBRIB 1214DA GUIDE WIRE WAS INTRODUCED INTO A PROWLER SELECT PLUS-J SHAPE MICRO CATHETER. AS SOON AS THE PHYSICIAN PULLED THE WIRE BACK, HE SAYS THAT THE WIRE WAS STUCK AND BROKE. THEY HAD TO PULL THE WHOLE SYSTEM OUT AND START OVER ON THIS SIDE. WHEN THEY MOVED ON TO TREAT THE OTHER SIDE, THEY USED A SWIFT NINJA STEERABLE MICRO CATHETER AND INTRODUCED A HYBRID 1214DA FOR THIS SIDE AS WELL, AND THE SAME THING HAPPENED. WHEN THEY PULLED THE WIRE BACK, THE WIRE WAS BROKEN." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721106 ↗
• MalfunctionNov 22, 2023Inaccurate Information; Inaccurate Information

  IT WAS IDENTIFIED DURING THE INVESTIGATION OF SUPPLIER BALT EXTRUSION'S HEALTH HAZARD EVALUATION PROCESS (BALT EXTRUSION HHE-030) THAT THE PRODUCT LOT NUMBER 00521955 MAY HAVE BEEN IMPACTED BY A POTENTIAL MIX-UP OF PRODUCTS. FOR THIS LOT NUMBER (00521955), THE INDICATED HYBRID GUIDEWIRE MODEL IS HYBRID1214DA ON THE POUCH AND CARTON LABEL. FOLLOWING BALT EXTRUSION'S INVESTIGATION, IT WAS NOTED THAT A POTENTIAL DEVICE MIX-UP MAY HAVE OCCURRED WITH ANOTHER MANUFACTURING LOT NUMBER (00520501) WHICH CORRESPONDS TO A DIFFERENT MODEL/GUIDEWIRE SIZE (HYBRID008J)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194814 ↗