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ZIPwire™ M006630200B0Recalls & 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 08714729875437), received between Sep 24, 2021 and Sep 24, 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

  • Foreign Body In Patient1

Recent adverse event reports

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

  • InjurySep 24, 2021Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

    PER MEDWATCH REPORT # (B)(4): FRAGMENT OF THE GLIDEWIRE USED TO PLACE THE R SUBCLAVIAN CVL SHEARED OFF THE DEVICE AND WAS RETAINED IN THE CENTRAL VENOUS SYSTEM FOLLOWING THE PROCEDURE.

    Patient problems: Foreign Body In Patient

    MAUDE report 12525995 ↗

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.