Zebra M0066701090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729752752), received between Sep 8, 2022 and Sep 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Unsealed Device Packaging; Unsealed Device Packaging

  T WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZEBRA GUIDEWIRE WAS USED DURING HOLMIUM LASER LITHOTRIPSY PROCEDURE ON (B)(6) 2022. DURING PREPARATION, ONE GUIDEWIRE IN A BOX OF FIVE WAS NOT SEALED AND HAD AN OPENING. THE STERILE BARRIER WAS COMPROMISED HOWEVER THERE WAS NO VISIBLE DAMAGE NOTED ON THE OUTER PACKAGING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND DEVICE WAS OUT OF STOCK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380261 ↗