Back-Up Meier H965SCH306000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729227878), received between Nov 12, 2018 and Dec 2, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 16, 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.

• MalfunctionDec 2, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING PEEL OCCURRED. A 035IN, 185CM, J, HOOPED BACK-UP MEIER GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE THE DEVICE COATING PEELED OFF AND WAS FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910226 ↗
• MalfunctionNov 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDE WIRE COATING PEELED OFF. A .035IN,185CM, J TIP, BACK-UP MEIER GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, DURING INSERTION OF THE DEVICE, IT WAS OBSERVED THAT THE CHUNKS OF THE WIRE COATING CAME OFF. IT WAS NOTICED ON THE GLOVES AND WHEN TRYING TO RUN A NON-BOSTON SCIENTIFIC CATHETER OVER THE GUIDE WIRE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870146 ↗
• MalfunctionNov 23, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. A 185CM PTA/MEIER GUIDEWIRE WAS SELECTED FOR TREATMENT. AFTER INSERTION OF THE GUIDEWIRE, IT WAS NOTED THAT FRAGMENTS OF THE GUIDEWIRE COATING HAD COME OFF. THE FRAGMENTS WERE OBSERVED ON THE USER'S GLOVES AFTER INSERTION AND WHEN TRYING TO RUN AN H1 AND PIGTAIL CATHETER OVER THE WIRE. THE WIRE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853145 ↗
• 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 15161532 ↗
• MalfunctionJul 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING PEELED OFF. A .035IN, 185CM, J TIP, B5 BACK-UP MEIER GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, MULTIPLE PLACES OF THE GUIDEWIRE COATING PEELED OFF. THE DEVICE WAS REMOVED AND NO COATING/WIRE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959867 ↗
• MalfunctionJul 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING PEELED OFF. A .035IN, 185CM, J TIP, B5 BACK-UP MEIER GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, MULTIPLE PLACES OF THE GUIDEWIRE COATING PEELED OFF. THE DEVICE WAS REMOVED AND NO COATING/WIRE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959853 ↗
• MalfunctionJul 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING PEELED OFF. A .035IN, 185CM, J TIP, B5 BACK-UP MEIER GUIDEWIRE WAS USED DURING THE PROCEDURE. HOWEVER, MULTIPLE PLACES OF THE GUIDEWIRE COATING PEELED OFF. THE DEVICE WAS REMOVED AND NO COATING/WIRE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959652 ↗
• MalfunctionApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE UPON ANALYSIS COMPLETED ON 30MAR2022. A NON-COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. HOWEVER, ANALYSIS REVEALED THE WIRE COATING HAD PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14059108 ↗
• MalfunctionNov 12, 2018Defective Device; Defective Device

  REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON NOVEMBER 2, 2018. IT WAS REPORTED THAT DURING THE USE INSERTION OF A 185CM, .035IN, J TIP BACK-UP MEIER GUIDEWIRE VIA A SHEATH IN THE AORTA, IT DID NOT PERFORM AS EXPECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO REPORTED PATIENT COMPLICATIONS. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED PEELING OF THE WIRE. DEVICE EVAL BY MANUFACTURER: THE DEVICE WAS RETURNED INSIDE THE HOOP. THE DISTAL SECTION IS KINKED AND SHOWS EVIDENCE OF FRICTION AS THE DEVICE HAS PART OF ITS COVER PEELED OFF. THE OVERALL LENGTH AND OUTER DIAMETER OF THE DISTAL TIP, MIDDLE, AND PROXIMAL SECTION WERE WITHIN SPECIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061653 ↗