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ZIPwire™ M006630206B0Recalls & reported problems

Lake Region Medical · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729761723), received between Oct 28, 2021 and Oct 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Damaged by Another Device1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryOct 28, 2021Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

    IT WAS REPORTED THAT: PIECES FRACTURES OFF WIRE WHILE IN FUNCTION. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. WHAT WAS THE OUTCOME OF THE PROCEDURE?: PROCEDURE CANCELLED OR RESCHEDULED IF UNSUCCESSFUL, WHY: YES. WAS THE PATIENT SEDATED WHEN THE PROCEDURE WAS CANCELLED?: YES. DEVICE USED TO COMPLETE PROCEDURE: NEW WIRE - SAME SIZE. RELATED TO A CLINICAL STUDY?: NO. ADDITIONAL INFORMATION PROVIDED ON 22 OCT 2021: WHEN IN THE PROCEDURE DID THE ISSUE OCCUR? UNKNOWN- THOUGH I THINK I PUT IT IN MY INITIAL COMPLAINT WAS THERE ANY PATIENT INJURY REPORTED? NO PATIENT COMPLICATIONS. WAS THIS THE FIRST TIME THE DEVICE WAS USED (NOT RESTERILIZED OR REPROCESSED)? YES. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE? NO. PER THE COMPLAINT FORM, IT WAS INDICATED THAT THE PROCEDURE WAS CANCELLED OR RESCHEDULED AS OUTCOME OF THE PROCEDURE; HOWEVER, IT WAS ALSO INDICATED THAT A DIFFERENT WIRE WAS USED TO COMPLETE THE PROCEDURE, COULD YOU PLEASE CLARIFY HOW THE PROCEDURE WAS COMPLETED? DID THEY USE A SECOND ZIPWIRE GUIDEWIRE AND COMPLETED THE PROCEDURE? YES. OR, DID THEY USE A DIFFERENT DEVICE (DIFFERENT MODEL)?NO. OR, WAS THE PROCEDURE NOT COMPLETED DUE TO ANOTHER REAS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12712382 ↗

Other Stylet, Ureteral devices

All Stylet, Ureteral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.