Z-MED™ 611806Recalls & reported problems
B Braun Interventional Systems, Inc · SO046 Z-MED 28X4X120 · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964338366), received between Apr 4, 2025 and Apr 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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.
Reports received per month
Most reported problems
Device problems
- Material Rupture1
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.
MalfunctionApr 4, 2025Material Rupture; Material Rupture
RECEIVED BY DISTRIBUTOR THROUGH THE MEDSUN REPORTING. WHILE DEPLOYING THE Z-MED BALLOON INSIDE THE VALVE IT RUPTURED. IT WAS THEN WRAPPED AROUND THE WIRE IN THE PATIENT. THE PHYSICIAN WAS ABLE TO PULL THE BALLOON OUT WITH DIFFICULTY, AND THE SHEATH IN THE GROIN WAS BENT DURING THE EXTRACTION PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775531 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.