Z-MED™ 610497Recalls & reported problems
B Braun Interventional Systems, Inc · PDZ347 Z-MED 18X4X100 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04046964329463), received between Feb 21, 2017 and Feb 21, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
Device problems
- Burst Container or Vessel1
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2017Burst Container or Vessel; Inflation Problem
AS PER THE REPORT FROM (B)(6): "WHILE DOING A VALVULOPLASTY, THE BALLOON BURST IN THE PATIENT BODY. THE BALLOON WAS BEING USED FOR SEVERE AS. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. A 9FR INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. PATIENT WAS FINE POST PROCEDURE. A SECOND BALLOON WAS NOT USED. THE BALLOON RUPTURED CIRCUMFERENTIALLY AT 4 ATM."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6347217 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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