Zebra M0066701120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729516385), received between Jan 5, 2022 and Mar 3, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT A ZEBRA GUIDEWIRE WAS INTENDED FOR USE DURING A UROLOGICAL SURGERY PERFORMED ON (B)(6) 2025. UPON UNPACKING, IT WAS FOUND THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494953 ↗
• InjurySep 26, 2024Break; Break

  IT WAS REPORTED THAT AT THE END OF A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE, WHILE THE PHYSICIAN WAS USING A GRASPER TO REPOSITION A STENT INSIDE THE PATIENT, A TWO INCHES THIN PIECE OF UNCOATED WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH THIS GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314142 ↗
• InjuryMay 16, 2024Break; Break

  IT WAS REPORTED THAT IN THE BEGINNING OF THE PROCEDURE, THE GUIDEWIRE LEFT SMALL PIECES INSIDE THE PATIENT BLADDER. THE PIECES WERE RETRIEVED USING A BASKET. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338084 ↗
• InjuryJan 5, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZEBRA GUIDEWIRE WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AT THE END OF THE CASE THE PHYSICIAN PLACED A STENT AND A FLURO IMAGE WAS TAKEN. IT WAS NOTED THAT PART OF THE WIRE BROKE OFF INSIDE THE KIDNEY DUE TO THE USE OF A NON-BSC LITHOTRIPTOR. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL ZEBRA GUIDEWIRE. IT WAS REPORTED THAT THE PHYSICIAN FELT IT WAS FINE AND WOULD RETRIEVE THE BROKEN FRAGMENT OF WIRE IN THE FOLLOW UP URETEROSCOPY BECAUSE HE DID NOT WANT TO TAKE OUT THE PLACED STENT. IN PHYSICIAN'S ASSESSMENT, THE DEVICE OR PROCEDURE DIDN'T CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 13172510 ↗