Z-5™ 611100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964333439), received between Mar 29, 2022 and Oct 11, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2023Material Rupture; Material Rupture

  AS PER THE REPORT FROM THE DISTRIBUTOR / USER FACILITY - BALLOON RUPTURE PRIOR TO BEING ABLE TO PERFORM SEPTOSTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914112 ↗
• InjuryFeb 16, 2023Patient-Device Incompatibility; Detachment of Device or Device Component; Patient-Device Incompatibility; Detachment of Device or Device Component

  AS PER THE REPORT RECEIVED FROM THE DISTRIBUTOR BIS, "UPON PULL BACK THE BALLOON AND MARKER BAND DETACHED FROM THE CATHETER AND EMBOLIZED TO THE LEFT SUBCLAVIAN ARTERY."

  Patient problems: Foreign Body In Patient

  MAUDE report 16387696 ↗
• InjuryMar 29, 2022Material Puncture/Hole; Material Puncture/Hole

  REPORTED TO NUMED AS A BALLOON PIN HOLE FROM THE USER FACILITY / DISTRIBUTOR. A MEDWATCH THAT WAS RECEIVED FROM THE FDA REPORTS IT AS A BALLOON BURST.

  Patient problems: Arrhythmia

  MAUDE report 13937686 ↗