Back-Up Meier H965SCH306010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729227892), received between May 13, 2019 and Aug 13, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 15JUL2025. IT WAS REPORTED THAT STRETCHED TIP OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A .035IN, 300CM BACK-UP MEIER GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION AND PRIOR TO ADMINISTERING ANESTHESIA, THE TIP WAS OBSERVED TO BE STRETCHED UPON UNPACKING. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED ANALYSIS REVEALED A DETACHED COREWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793439 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIP WAS DETACHED. VASCULAR ACCESS WAS OBTAINED BY PUNCTURING THE RIGHT FEMORAL ARTERY AND THE PATIENT WAS PLACED IN THE SUPINE POSITION. A .035IN 300CM BACK-UP MEIER GUIDEWIRE WAS SELECTED FOR OCCLUSION OF THE PATENT FORAMEN OVALE. HOWEVER, THE TIP OF THE WIRE WAS FOUND DETACHED WHEN IT WAS UNPACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME TYPE OF DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250926 ↗
• MalfunctionJun 21, 2024Material Integrity Problem; Nonstandard Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERATRIAL VASCULATURE. A .035IN, 300CM BACK-UP MEIER WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE END OF THE GUIDEWIRE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585587 ↗
• MalfunctionApr 11, 2024Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A .035IN, 300CM EX/C TIP B/5 BACK-UP MEIER GUIDEWIRE WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE GUIDEWIRE WAS UNWINDING AT ITS TIP AND THE WIRE OF THE SHAFT WAS VISUALLY FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093379 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN .035 IN, 300 CM BACK-UP MEIER GUIDEWIRE WAS PREPARED FOR AN ENDOVASCULAR ISOLATION OF ABDOMINAL AORTIC ANEURYSM ON THE PATIENT. WHEN THE DEVICE WAS TAKEN OUT OF ITS PACKAGE, IT WAS NOTED THAT THE DISTAL TIP WAS DETACHED FROM THE GUIDEWIRE. ANOTHER OF THE SAME DEVICE WAS USED IN COMPLETING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234134 ↗
• MalfunctionJul 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING UNPACKING OF A .035IN, 300CM EX/C TIP B/5 BACK-UP MEIER GUIDEWIRE, IT WAS FOUND THAT THE TIP OF THE WIRE WAS UNSCREWED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352273 ↗
• MalfunctionAug 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING UNRAVELED. TWO 0.035IN, 185CM, J TIP BACK-UP MEIER GUIDEWIRES WERE USED IN A TAVR PROCEDURE. WHILE ADVANCING THE GUIDEWIRE THROUGH THE SHEATH, THE GUIDEWIRE'S COATING UNRAVELED. THIS OCCURRED ON BOTH DEVICES. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161537 ↗
• MalfunctionMay 13, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24 APR 2019. IT WAS REPORTED THAT GUIDEWIRE DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A .035IN, 300CM PTA/MEIER GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE DEVICE WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE CORE WIRE WAS DETACHED/SEPARATED.

  Patient problems: No Patient Involvement

  MAUDE report 8605841 ↗