ATTAIN HYBRID™ Guide Wire GWR419588Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169452411), received between Dec 7, 2017 and May 13, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE BROKE OFF INSIDE THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS REMOVED AND THE GUIDEWIRE WAS SUCCESSFULLY REMOVED FROM THE DISTAL LEAD TIP. A REPLACEMENT LEAD WAS SUCCESSFULLY IMPLANTED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS RETURNED TO THE MANUFACTURER AFTER USE WITH NO REASON FOR THE RETURN. THE GUIDEWIRE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300865 ↗
• InjuryApr 4, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER ACCESSING THE CORONARY SINUS AND TRYING TO PLACE THE LEFT VENTRICULAR (LV) LEAD IN THE POSTEROLATERAL VEIN, THE PHYSICIAN INJECTED CONTRAST AND EXTRAVASATION OF THE CONTRAST WAS OBSERVED IN THE AREA WHERE THE GUIDEWIRE HAD BEEN MANIPULATED. IT WAS NOTED THAT THE PATIENT HAD CHEST PAIN AND EXPERIENCED A VAGAL REACTION BUT RECOVERED WITHOUT ANY ISSUES AFTER SERUM THERAPY AND MEDICATION. AN ECHO REVEALED A SLIGHT DETACHMENT OF PERICARDIAL LEAVES AROUND THE RIGHT VENTRICLE AND THE RIGHT ATRIOVENTRICULAR GROOVE. DUE TO THIS ISSUE THE PROCEDURE WAS ABORTED. THE LEAD WAS NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 13997454 ↗
• MalfunctionMar 4, 2022Material Fragmentation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Integrity Problem; Material Fragmentation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HYBRID GUIDEWIRE THAT WAS INSERTED IN THE LEAD HAD FORMED A KNOT AND WAS LIKELY STUCK IN A DISTAL CAPILLARY OF THE VESSEL. WHILE THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE, IT BECAME FRAYED. A PORTION OF THE GUIDEWIRE WAS REMOVE, BUT A PIECE OF THE SOFT PART REMAINED STICK IN THE VESSEL. A REPLACEMENT GUIDEWIRE WAS USED TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667707 ↗
• MalfunctionMar 26, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE TIP OF THE GUIDEWIRE WAS NOTED TO BE TWISTED/CURLED AND THE PHYSICIAN WAS UNABLE TO INSERT THE GUIDEWIRE INTO THE LEAD. THE GUIDEWIRE WAS NOT USED. SUBSEQUENTLY, THE GUIDEWIRE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578452 ↗
• MalfunctionJan 3, 2020Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE TIP OF THE GUIDEWIRE DETACHED AND REMAINED IN THE CORONARY SINUS. IT WAS NOTED TO BE THE THIN BLACK PART OF THE GUIDEWIRE. ANOTHER GUIDEWIRE WAS USED FOR IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9548911 ↗
• MalfunctionApr 17, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE, THE DISTAL PORTION OF THE GUIDEWIRE WAS STRETCHED UPON REMOVAL FROM THE PACKAGE. IT WAS NOTED THAT THE PLASTIC CASSETTE PACKAGING WAS INTACT. THE GUIDEWIRE WAS NOT USED, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8524678 ↗
• MalfunctionMay 19, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER REMOVAL OF THE GUIDEWIRE FROM THE LEAD, IT WAS NOTICED THAT THE DISTAL TIP OF THE GUIDEWIRE APPEARED TO HAVE UNRAVELED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7528491 ↗
• MalfunctionMay 18, 2018Material Fragmentation; Device Or Device Fragments Location Unknown; Material Fragmentation; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, PART OF THE GUIDEWIRE HAD BROKEN AND WAS VISIBLE AT THE END OF THE VEIN. IT WAS NOTED THAT WHEN PLACING THE LV LEAD, THE PHYSICIAN REMOVED THE GUIDEWIRE AND OBSERVED ON THE FLUOROSCOPIC IMAGE THAT PART OF THE GUIDEWIRE WAS BROKEN. THE PART OF THE GUIDEWIRE THAT WAS BROKEN WILL REMAIN INSIDE THE PATIENT AND THE REMAINING PART THAT WAS REMOVED WILL BE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526577 ↗
• MalfunctionDec 7, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHEN THE GUIDEWIRE WAS REMOVED FROM THE PACKAGING, THE DISTAL END OF THE HYBRIDWIRE SEPARATED. THE GUIDEWIRE WAS NOT USED WITH THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7090729 ↗