ATTAIN HYBRID™ Guide Wire GWR419688Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169452398), received between Oct 17, 2018 and Mar 2, 2026 — classified as 1 death, 2 injuries, 3 malfunctions.

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

• InjuryMar 2, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PREVIOUS PRE-OPERATIVE ECHOCARDIOGRAMS CONFIRMED THAT THE PATIENT HAD A SPACE IN THE PERICARDIUM CONSISTENT WITH WHAT WAS THOUGHT TO BE AN EFFUSION. THE PHYSICIAN CONFIRMED THAT THE LEAD EXTRACTION HAD NO CONSEQUENCE ON THE ECHOCARDIOGRAM FINDINGS, AND WAS NOT THE CAUSE OF POST-OPERATIVE HYPOTENSION.

  Patient problems: Headache; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24491842 ↗
• InjuryFeb 17, 2026Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING IMPLANT, THERE WAS DIFFICULTY IN ATTEMPTING TO REMOVE THE GUIDEWIRE AND IT BROKE INSIDE THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE PROCEDURE HAD BEEN VERY LONG AND THE PHYSICIAN INTENDED TO REPLACE THE LV LEAD ON ANOTHER DAY. THE PATIENT DECIDED THAT THEY DIDN¿T WANT TO DO THIS AND THE LV LEAD WAS IMPLANTED WITH THE GUIDEWIRE LEFT INSIDE THE PATIENT¿S BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367453 ↗
• MalfunctionOct 27, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT PRIOR TO USE THE GUIDEWIRE APPEARANCE WAS NOT AS EXPECTED AND WAS NOTED TO BE BENT. THE GUIDEWIRE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THE GUIDEWIRE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680098 ↗
• DeathAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD AND USE OF THE CATHETER, IT WAS OBSERVED THAT THE GUIDEWIRE AND THE LEAD WERE ADVANCING DOWN A NON-VISUALIZED PATH ON THE VENOGRAM. A CORONARY SINUS DISSECTION HAD OCCURRED, THE PATIENT'S BLOOD PRESSURE WAS LOW, AND A CODE WAS CALLED. THE LEAD, THE CATHETER, THE SHEATH AND THE GUIDEWIRE WERE REMOVED IMMEDIATELY. PERICARDIAL EFFUSION AND TAMPONADE FROM THE PERFORATION WERE OBSERVED. PULSELESS ELECTRICAL ACTIVITY (PEA) WAS DIAGNOSED AND RESCUE ATTEMPTS WERE PERFORMED. THE PHYSICIAN PERFORMED A STERNOTOMY TO EVACUATE THE CAVITY AND REPAIR HEART. BLOOD AND FLUID WAS SUCCESSFULLY REMOVED TO RELIEVE TAMPONADE AND THE TEAR WAS SURGICALLY REPAIRED. THE PATIENT WAS GIVEN FOUR UNITS OF BLOOD. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND PASSED AWAY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion; Vascular Dissection

  MAUDE report 15212185 ↗
• MalfunctionApr 5, 2019Material Fragmentation; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Fragmentation; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE LEFT VENTRICULAR (LV) LEAD WAS PLACED, THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE FROM THE LEAD. IT WAS NOTED THAT THE GUIDEWIRE WAS FOLDED BACKWARDS, AND THE PHYSICIAN APPLIED FORCE TO REMOVE THE GUIDEWIRE CAUSING IT TO BREAK. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF THE GUIDEWIRE WAS TRAPPED INSIDE THE LEAD AND THE OTHER PART WAS LOCATED OUTSIDE OF THE LEAD AND INSIDE THE PATIENT VEIN. THE IMPLANTING PHYSICIANS DECIDED TO LEAVE THE BROKEN PORTION OF THE GUIDEWIRE INSIDE THE PATIENT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488766 ↗
• MalfunctionOct 17, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE BEGAN TO UNRAVEL WHILST IN THE LEAD. THIS MEANT THAT THE GUIDEWIRE COULD NOT BE MOVED WITHIN THE LEAD. BOTH LEAD AND GUIDEWIRE WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7975082 ↗